| | Class 2 Device Recall GE Healthcare Centricity |  |
| Date Initiated by Firm | July 23, 2024 |
| Date Posted | September 17, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3160-2024 |
| Recall Event ID |
95238 |
| 510(K)Number | K131977 |
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers:
a) 2110344-008;
b) 2110344-009;
c) 2110344-010;
d) 2110344-011;
e) 2110344-013;
f) 2110344-019;
g) 2110344-025;
h) 2110344-029;
i) 2110344-030;
j) 2110344-032
; Radiological image processing system |
| Code Information |
UDI/DI: 00840682102988:
a) 2110344-008, Installed Product ID Numbers: B54834-Centricity Universal Viewer Zero Footprint / ZFP-02394744, KMCH-Centricity Universal Viewer Zero Footprint / ZFP-01819848, 355920-Centricity Universal Viewer Zero Footprint / ZFP-20996307, 225717-Centricity Universal Viewer Zero Footprint / ZFP-19666806, RF0827-Centricity Universal Viewer Zero Footprint / ZFP-19460712;
b) 2110344-009, Installed Product ID Numbers: 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372918, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348000, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348009, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348010, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348035, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-19632983, SA1008-Centricity Universal Viewer Zero Footprint / ZFP-20620864;
c) 2110344-010, Installed Product ID Numbers: 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098227, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098228, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-14194760, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023936, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023938, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023939, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023940, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023941, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023942, 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-17192653, 1472-19-Centricity Universal Viewer Zero Footprint / ZFP-22125883, 946739-Centricity Universal Viewer Zero Footprint / ZFP-14767595, 753891-Centricity Universal Viewer Zero Footprint / ZFP-21739897, 753891-Centricity Universal Viewer Zero Footprint / ZFP-19737302, JP-340499-Centricity Universal Viewer Zero Footprint / ZFP-01275434, RU8902-Centricity Universal Viewer Zero Footprint / ZFP-17775055, RU9383-Centricity Universal Viewer Zero Footprint / ZFP-16868184;
d) 2110344-011, Installed Product ID Numbers: 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-01564901, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098755, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098757, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098758, 4084-1-Centricity Universal Viewer Zero Footprint / ZFP-02301039, 100085-5-Centricity Universal Viewer Zero Footprint / ZFP-20036722;
e) 2110344-013, Installed Product ID Numbers: RU1473-Centricity Universal Viewer Zero Footprint / ZFP-02331227, RU3152-Centricity Universal Viewer Zero Footprint / ZFP-02314018, RF1194-Centricity Universal Viewer Zero Footprint / ZFP-19716329, RU6265-Centricity Universal Viewer Zero Footprint / ZFP-20080267, RU1107-Centricity Universal Viewer Zero Footprint / ZFP-01620728, RU9227-Centricity Universal Viewer Zero Footprint / ZFP-20080351, RU8412-Centricity Universal Viewer Zero Footprint / ZFP-19727241, RU7361-Centricity Universal Viewer Zero Footprint / ZFP-20084480;
f) 2110344-019, Installed Product ID Numbers: 104586-2-Centricity Universal Viewer Zero Footprint / ZFP-01299076, 8121-6-Centricity Universal Viewer Zero Footprint / ZFP-01808438, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01367875, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372919, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372920, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372921, 1472-15-Centricity Universal Viewer Zero Footprint / ZFP-01372922, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-00556036, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-00556037, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347655, 444402-Centricity Universal Viewer Zero Footprint / ZFP-20091853, JP-340206-Centricity Universal Viewer Zero Footprint / ZFP-01275380, JP-690277-Centricity Universal Viewer Zero Footprint / ZFP-19665249;
g) 2110344-025, Installed Product ID Numbers: 104440-1-Centricity Universal Viewer Zero Footprint / ZFP-23264377, RU1152-Centricity Universal Viewer Zero Footprint / ZFP-20579574;
h) 2110344-029, Installed Product ID Numbers: 105906-2-Centricity Universal Viewer Zero Footprint / ZFP-02312614, 4653-1-Centricity Universal Viewer Zero Footprint / ZFP-00161865, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02371135, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02371136, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02371137, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02371138, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02371139, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-01983569, 10414-1-Centricity Universal Viewer Zero Footprint / ZFP-02257545, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609719, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609721, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609722, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609724, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609725, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609727, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609728, 4049-1-Centricity Universal Viewer Zero Footprint / ZFP-01805026, 4049-1-Centricity Universal Viewer Zero Footprint / ZFP-02302924, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-01477454, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286832, 3805-14-Centricity Universal Viewer Zero Footprint / ZFP-02098759, 1275-6-Centricity Universal Viewer Zero Footprint / ZFP-00161288, 1275-6-Centricity Universal Viewer Zero Footprint / ZFP-00161686, 1275-6-Centricity Universal Viewer Zero Footprint / ZFP-00161687, 1275-6-Centricity Universal Viewer Zero Footprint / ZFP-18469046, 1275-6-Centricity Universal Viewer Zero Footprint / ZFP-20653788, 106710-1-Centricity Universal Viewer Zero Footprint / ZFP-01810611, 106710-1-Centricity Universal Viewer Zero Footprint / ZFP-14768105, 106710-1-Centricity Universal Viewer Zero Footprint / ZFP-14769712, 102753-1-Centricity Universal Viewer Zero Footprint / ZFP-01810676, 102753-1-Centricity Universal Viewer Zero Footprint / ZFP-01978730, 102753-1-Centricity Universal Viewer Zero Footprint / ZFP-01978731, 102753-1-Centricity Universal Viewer Zero Footprint / ZFP-01978732, 105525-1-Centricity Universal Viewer Zero Footprint / ZFP-02315655, 105525-1-Centricity Universal Viewer Zero Footprint / ZFP-21306260, 104015-1-Centricity Universal Viewer Zero Footprint / ZFP-02157305, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-01740249, 3212-8-Centricity Universal Viewer Zero Footprint / ZFP-14761752, 3212-5-Centricity Universal Viewer Zero Footprint / ZFP-02157261, 10547-2-Centricity Universal Viewer Zero Footprint / ZFP-01294055, 10547-2-Centricity Universal Viewer Zero Footprint / ZFP-02337580, 9915-2-Centricity Universal Viewer Zero Footprint / ZFP-01459010, 9915-2-Centricity Universal Viewer Zero Footprint / ZFP-02257259, 9866-2-Centricity Universal Viewer Zero Footprint / ZFP-00101400, 9866-2-Centricity Universal Viewer Zero Footprint / ZFP-00101401, 10832-3-Centricity Universal Viewer Zero Footprint / ZFP-21207910, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 4289-3-Centricity Universal Viewer Zero Footprint / ZFP-01976550, 102193-2-Centricity Universal Viewer Zero Footprint / ZFP-14765252, 1609-1-Centricity Universal Viewer Zero Footprint / ZFP-02344894, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-22188687, 3719-9-Centricity Universal Viewer Zero Footprint / ZFP-00161362, 3719-9-Centricity Universal Viewer Zero Footprint / ZFP-00161368, 3066-1-Centricity Universal Viewer Zero Footprint / ZFP-00101769, 3066-1-Centricity Universal Viewer Zero Footprint / ZFP-00101770, 3719-1-Centricity Universal Viewer Zero Footprint / ZFP-01987326, 1331-24-Centricity Universal Viewer Zero Footprint / ZFP-02041554, 1331-24-Centricity Universal Viewer Zero Footprint / ZFP-02190655, 11673-4-Centricity Universal Viewer Zero Footprint / ZFP-01814396, 101647-1-Centricity Universal Viewer Zero Footprint / ZFP-02205362, 106558-2-Centricity Universal Viewer Zero Footprint / ZFP-01987441, 4204-1-Centricity Universal Viewer Zero Footprint / ZFP-01459008, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-02341586, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-02354814, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-02354815, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-02354816, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291321, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291322, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291332, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291333, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291334, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-15291335, 6901-11-Centricity Universal Viewer Zero Footprint / ZFP-16355110, 105461-1-Centricity Universal Viewer Zero Footprint / ZFP-02035195, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-01974088, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-02354817, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-02354818, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-02354819, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-02354820, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-15291319, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-15291320, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-17594364, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-19020773, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-19020774, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-20621990, 6901-12-Centricity Universal Viewer Zero Footprint / ZFP-20621993, 1847-3-Centricity Universal Viewer Zero Footprint / ZFP-02097811, 1847-3-Centricity Universal Viewer Zero Footprint / ZFP-02255598, 1847-2-Centricity Universal Viewer Zero Footprint / ZFP-00169967, 1847-2-Centricity Universal Viewer Zero Footprint / ZFP-00169968, 1847-2-Centricity Universal Viewer Zero Footprint / ZFP-00169969, 1696-1-Centricity Universal Viewer Zero Footprint / ZFP-20694814, 1696-1-Centricity Universal Viewer Zero Footprint / ZFP-20699361, 1696-1-Centricity Universal Viewer Zero Footprint / ZFP-02186950, 1696-1-Centricity Universal Viewer Zero Footprint / ZFP-02269625, 100729-1-Centricity Universal Viewer Zero Footprint / ZFP-01721608, 6051-Centricity Universal Viewer Zero Footprint / ZFP-02277661, 2892781_Stvincentssyd-Centricity Universal Viewer Zero Footprint / ZFP-02186467, 1698348_Alfred-Centricity Universal Viewer Zero Footprint / ZFP-02032817, 1586578_Nedlands-Centricity Universal Viewer Zero Footprint / ZFP-20034444, 123456-Centricity Universal Viewer Zero Footprint / ZFP-14310910, 423834-Centricity Universal Viewer Zero Footprint / ZFP-24370371, 423834-Centricity Universal Viewer Zero Footprint / ZFP-24370372, 423834-Centricity Universal Viewer Zero Footprint / ZFP-24370373, 333266-Centricity Universal Viewer Zero Footprint / ZFP-16482049, 13628-Centricity Universal Viewer Zero Footprint / ZFP-02336211, 104295-2-Centricity Universal Viewer Zero Footprint / ZFP-01286791, 631789-Centricity Universal Viewer Zero Footprint / ZFP-01286792, 631789-Centricity Universal Viewer Zero Footprint / ZFP-21268829, B0201-12-Centricity Universal Viewer Zero Footprint / ZFP-02031960, 2227709-Centricity Universal Viewer Zero Footprint / ZFP-20080947, 1301843-Centricity Universal Viewer Zero Footprint / ZFP-14430019, S540080-Centricity Universal Viewer Zero Footprint / ZFP-00043934, M44850-Centricity Universal Viewer Zero Footprint / ZFP-01817813, M41884-Centricity Universal Viewer Zero Footprint / ZFP-02345947, PF1005-Centricity Universal Viewer Zero Footprint / ZFP-02301061, PF1005-Centricity Universal Viewer Zero Footprint / ZFP-02301134, U1982906 / NC1076-Centricity Universal Viewer Zero Footprint / ZFP-01987930, 4625913X - HC0565-Centricity Universal Viewer Zero Footprint / ZFP-00545594, X9000399 - HC0399-Centricity Universal Viewer Zero Footprint / ZFP-01282975, HC1451-Centricity Universal Viewer Zero Footprint / ZFP-01288243, 1657844X - 518086-Centricity Universal Viewer Zero Footprint / ZFP-00158637, X9000245 - HC0245-Centricity Universal Viewer Zero Footprint / ZFP-01462020, 362144-Centricity Universal Viewer Zero Footprint / ZFP-02263754, PC0070-Centricity Universal Viewer Zero Footprint / ZFP-02042361, UHAM02-Centricity Universal Viewer Zero Footprint / ZFP-00059329, X9003387 - HHEI01-Centricity Universal Viewer Zero Footprint / ZFP-21310713, 434487-Centricity Universal Viewer Zero Footprint / ZFP-22169581, 145774-Centricity Universal Viewer Zero Footprint / ZFP-01814045, 1257845X - 434487-Centricity Universal Viewer Zero Footprint / ZFP-22203508, 0828550068-Centricity Universal Viewer Zero Footprint / ZFP-02094418, 828550053-Centricity Universal Viewer Zero Footprint / ZFP-02253600, 434519-Centricity Universal Viewer Zero Footprint / ZFP-20677457, A1892038-Centricity Universal Viewer Zero Footprint / ZFP-02093306, A56306-Centricity Universal Viewer Zero Footprint / ZFP-02180921, A56600-Centricity Universal Viewer Zero Footprint / ZFP-01454929, A6700602-Centricity Universal Viewer Zero Footprint / ZFP-02178761, A60858-Centricity Universal Viewer Zero Footprint / ZFP-02286910, JP-380108-Centricity Universal Viewer Zero Footprint / ZFP-02255381, JP-340255-Centricity Universal Viewer Zero Footprint / ZFP-01974303, JP-280245-Centricity Universal Viewer Zero Footprint / ZFP-02255463, JP-280250-Centricity Universal Viewer Zero Footprint / ZFP-02360544, JP-140140-Centricity Universal Viewer Zero Footprint / ZFP-02154910, JP-140051-Centricity Universal Viewer Zero Footprint / ZFP-02099295, JP-290033-Centricity Universal Viewer Zero Footprint / ZFP-01275435, JP-290033-Centricity Universal Viewer Zero Footprint / ZFP-01275437, JP-290033-Centricity Universal Viewer Zero Footprint / ZFP-01275438, JP-250378-Centricity Universal Viewer Zero Footprint / ZFP-02186431, JP-090905-Centricity Universal Viewer Zero Footprint / ZFP-02041046, JP-130422-Centricity Universal Viewer Zero Footprint / ZFP-01980318, JP-130527-Centricity Universal Viewer Zero Footprint / ZFP-02093919, JP-130626-Centricity Universal Viewer Zero Footprint / ZFP-02043333, JP-130761-Centricity Universal Viewer Zero Footprint / ZFP-02248293, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02156484, 60020_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02307677, 60020_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02291060, 709434-Centricity Universal Viewer Zero Footprint / ZFP-14765518, SA1075-Centricity Universal Viewer Zero Footprint / ZFP-01457247, UP285A-Centricity Universal Viewer Zero Footprint / ZFP-01815172, GPX458-Centricity Universal Viewer Zero Footprint / ZFP-01980394, GPX459-Centricity Universal Viewer Zero Footprint / ZFP-01980471, GPQ131-Centricity Universal Viewer Zero Footprint / ZFP-02254265, 407237-Centricity Universal Viewer Zero Footprint / ZFP-02290167, 529010-Centricity Universal Viewer Zero Footprint / ZFP-01824677, 34433-Centricity Universal Viewer Zero Footprint / ZFP-01294788, 16798599-Centricity Universal Viewer Zero Footprint / ZFP-01475999, 34435-Centricity Universal Viewer Zero Footprint / ZFP-00545336, 34449-Centricity Universal Viewer Zero Footprint / ZFP-22226438, 80674-Centricity Universal Viewer Zero Footprint / ZFP-01425411, 80674-Centricity Universal Viewer Zero Footprint / ZFP-21318253;
i) 2110344-030, Installed Product ID Numbers: 4084-1-Centricity Universal Viewer Zero Footprint / ZFP-19600711, 9862-1-Centricity Universal Viewer Zero Footprint / ZFP-00100263, 9862-1-Centricity Universal Viewer Zero Footprint / ZFP-14765956, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096091, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348002, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, 1503588-Centricity Universal Viewer Zero Footprint / ZFP-14549617, 6891796-Centricity Universal Viewer Zero Footprint / ZFP-19631000, 306184-Centricity Universal Viewer Zero Footprint / ZFP-19620282, 324227-Centricity Universal Viewer Zero Footprint / ZFP-02040656, 320092-Centricity Universal Viewer Zero Footprint / ZFP-19675475, 329997-Centricity Universal Viewer Zero Footprint / ZFP-19732482, 3440585-Centricity Universal Viewer Zero Footprint / ZFP-02286138, 3440585-Centricity Universal Viewer Zero Footprint / ZFP-20092101, 327750-Centricity Universal Viewer Zero Footprint / ZFP-20904827, JP-380123-Centricity Universal Viewer Zero Footprint / ZFP-20101283, JP-400021-Centricity Universal Viewer Zero Footprint / ZFP-19649615, JP-030135-Centricity Universal Viewer Zero Footprint / ZFP-01275425, JP-420052-Centricity Universal Viewer Zero Footprint / ZFP-14761038, JP-420052-Centricity Universal Viewer Zero Footprint / ZFP-15111121, JP-420052-Centricity Universal Viewer Zero Footprint / ZFP-15111126, JP-272900-Centricity Universal Viewer Zero Footprint / ZFP-02041843, JP-270263-Centricity Universal Viewer Zero Footprint / ZFP-01275411, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-01299106, 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181, 328816-Centricity Universal Viewer Zero Footprint / ZFP-17805275, 4879575-Centricity Universal Viewer Zero Footprint / ZFP-15743070, U-4J5U54-Centricity Universal Viewer Zero Footprint / ZFP-01455930, RU7579-Centricity Universal Viewer Zero Footprint / ZFP-18957266, 41400-Centricity Universal Viewer Zero Footprint / ZFP-02291025;
j) 2110344-032, Installed Product ID Numbers: 3915-10-Centricity Universal Viewer Zero Footprint / ZFP-02360681, 3915-10-Centricity Universal Viewer Zero Footprint / ZFP-18867313, 4653-1-Centricity Universal Viewer Zero Footprint / ZFP-00161866, 4653-1-Centricity Universal Viewer Zero Footprint / ZFP-19618935, 4653-1-Centricity Universal Viewer Zero Footprint / ZFP-21780800, 103710-1-Centricity Universal Viewer Zero Footprint / ZFP-02308031, 104586-2-Centricity Universal Viewer Zero Footprint / ZFP-23066609, 4415-6-Centricity Universal Viewer Zero Footprint / ZFP-01810693, 2195-15-Centricity Universal Viewer Zero Footprint / ZFP-01291411, 2195-15-Centricity Universal Viewer Zero Footprint / ZFP-00165673, 2195-15-Centricity Universal Viewer Zero Footprint / ZFP-00168142, 2195-15-Centricity Universal Viewer Zero Footprint / ZFP-00168143, 2195-15-Centricity Universal Viewer Zero Footprint / ZFP-01448429, 2195-10-Centricity Universal Viewer Zero Footprint / ZFP-20999747, 105281-1-Centricity Universal Viewer Zero Footprint / ZFP-01820425, 100256-3-Centricity Universal Viewer Zero Footprint / ZFP-01810795, 100256-3-Centricity Universal Viewer Zero Footprint / ZFP-19604803, 100256-3-Centricity Universal Viewer Zero Footprint / ZFP-19604804, 100256-3-Centricity Universal Viewer Zero Footprint / ZFP-19604805, 100256-3-Centricity Universal Viewer Zero Footprint / ZFP-19604806, 4415-8-Centricity Universal Viewer Zero Footprint / ZFP-20274847, 4415-2-Centricity Universal Viewer Zero Footprint / ZFP-19609729, 4415-7-Centricity Universal Viewer Zero Footprint / ZFP-20274843, 8142-4-Centricity Universal Viewer Zero Footprint / ZFP-02397428, 8142-4-Centricity Universal Viewer Zero Footprint / ZFP-19715369, 8142-4-Centricity Universal Viewer Zero Footprint / ZFP-19715370, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-00099694, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-01294051, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-02350740, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-16265092, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20019523, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20019524, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20019525, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20019526, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20019527, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20036734, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20036735, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20036736, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-20036737, 105953-2-Centricity Universal Viewer Zero Footprint / ZFP-02345969, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-22268979, 100620-23-Centricity Universal Viewer Zero Footprint / ZFP-22268125, 103696-8-Centricity Universal Viewer Zero Footprint / ZFP-16868149, 4420-6-Centricity Universal Viewer Zero Footprint / ZFP-01810727, 4420-6-Centricity Universal Viewer Zero Footprint / ZFP-20032680, 4420-6-Centricity Universal Viewer Zero Footprint / ZFP-20032681, 4420-6-Centricity Universal Viewer Zero Footprint / ZFP-20032690, 2204-1-Centricity Universal Viewer Zero Footprint / ZFP-01893572, 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165278, 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-00165279, 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-02337066, 2317-3-Centricity Universal Viewer Zero Footprint / ZFP-02337067, 105441-1-Centricity Universal Viewer Zero Footprint / ZFP-01987335, 105950-1-Centricity Universal Viewer Zero Footprint / ZFP-02344194, 105950-1-Centricity Universal Viewer Zero Footprint / ZFP-02369612, 103835-2-Centricity Universal Viewer Zero Footprint / ZFP-02314205, 103835-2-Centricity Universal Viewer Zero Footprint / ZFP-02336078, 103835-2-Centricity Universal Viewer Zero Footprint / ZFP-15050663, 103835-2-Centricity Universal Viewer Zero Footprint / ZFP-15050664, 103835-2-Centricity Universal Viewer Zero Footprint / ZFP-15050665, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286833, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286834, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286835, 103944-3-Centricity Universal Viewer Zero Footprint / ZFP-02286836, 10345-1-Centricity Universal Viewer Zero Footprint / ZFP-01419025, 10345-1-Centricity Universal Viewer Zero Footprint / ZFP-02189674, 10345-9-Centricity Universal Viewer Zero Footprint / ZFP-01425634, 10363-2-Centricity Universal Viewer Zero Footprint / ZFP-00555476, 10363-2-Centricity Universal Viewer Zero Footprint / ZFP-21992896, 104473-1-Centricity Universal Viewer Zero Footprint / ZFP-01813754, 10388-1-Centricity Universal Viewer Zero Footprint / ZFP-14762271, 10388-1-Centricity Universal Viewer Zero Footprint / ZFP-19714873, 10388-1-Centricity Universal Viewer Zero Footprint / ZFP-19714877, 10388-1-Centricity Universal Viewer Zero Footprint / ZFP-19714878, 10536-1-Centricity Universal Viewer Zero Footprint / ZFP-00161373, 10536-1-Centricity Universal Viewer Zero Footprint / ZFP-00161372, 10536-1-Centricity Universal Viewer Zero Footprint / ZFP-21325653, 1635-8-Centricity Universal Viewer Zero Footprint / ZFP-18227238, 9880-6-Centricity Universal Viewer Zero Footprint / ZFP-21775960, 102719-1-Centricity Universal Viewer Zero Footprint / ZFP-00098294, 102719-1-Centricity Universal Viewer Zero Footprint / ZFP-00098295, 102719-6-Centricity Universal Viewer Zero Footprint / ZFP-21318832, 100171-15-Centricity Universal Viewer Zero Footprint / ZFP-20869504, 100171-15-Centricity Universal Viewer Zero Footprint / ZFP-00098296, B0201-64-Centricity Universal Viewer Zero Footprint / ZFP-22255230, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 102768-1-Centricity Universal Viewer Zero Footprint / ZFP-02302156, 10283-1-Centricity Universal Viewer Zero 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ZFP-19715420, JP-110043-Centricity Universal Viewer Zero Footprint / ZFP-19715639, JP-250031-Centricity Universal Viewer Zero Footprint / ZFP-02399308, JP-220238-Centricity Universal Viewer Zero Footprint / ZFP-14764727, JP-130644-Centricity Universal Viewer Zero Footprint / ZFP-20084064, JP-130314-Centricity Universal Viewer Zero Footprint / ZFP-02274906, JP-130314-Centricity Universal Viewer Zero Footprint / ZFP-19616515, JP-130440-Centricity Universal Viewer Zero Footprint / ZFP-01979557, JP-130440-Centricity Universal Viewer Zero Footprint / ZFP-01979560, JP-130440-Centricity Universal Viewer Zero Footprint / ZFP-02040264, JP-130539-Centricity Universal Viewer Zero Footprint / ZFP-02304194, JP-130539-Centricity Universal Viewer Zero Footprint / ZFP-02332756, JP-130539-Centricity Universal Viewer Zero Footprint / ZFP-02332757, JP-130067-Centricity Universal Viewer Zero Footprint / ZFP-20483773, JP-131312-Centricity Universal Viewer Zero Footprint / ZFP-20617592, JP-300074-Centricity Universal Viewer Zero Footprint / ZFP-20509115, JP-300048-Centricity Universal Viewer Zero Footprint / ZFP-01275433, JP-300048-Centricity Universal Viewer Zero Footprint / ZFP-21210229, 851746-Centricity Universal Viewer Zero Footprint / ZFP-20923876, 851894-Centricity Universal Viewer Zero Footprint / ZFP-01973237, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-19638454, KW1007-Centricity Universal Viewer Zero Footprint / ZFP-14549479, KW1096-Centricity Universal Viewer Zero Footprint / ZFP-20541640, LB1160-Centricity Universal Viewer Zero Footprint / ZFP-01591506, SGB-MY-Centricity Universal Viewer Zero Footprint / ZFP-19630188, 2348649-Centricity Universal Viewer Zero Footprint / ZFP-14769747, HUSM-Centricity Universal Viewer Zero Footprint / ZFP-19614903, IPPT-Centricity Universal Viewer Zero Footprint / ZFP-19614914, 1322427-Centricity Universal Viewer Zero Footprint / ZFP-19660792, MSU-MY-Centricity Universal Viewer Zero Footprint / ZFP-01893497, 5499-Centricity Universal Viewer Zero Footprint / ZFP-14868737, 332068-Centricity Universal Viewer Zero Footprint / ZFP-20870045, PER503-Centricity Universal Viewer Zero Footprint / ZFP-21037599, SA2128-Centricity Universal Viewer Zero Footprint / ZFP-21330000, 2978539-Centricity Universal Viewer Zero Footprint / ZFP-22213020, SA1060-Centricity Universal Viewer Zero Footprint / ZFP-00066963, SA1060-Centricity Universal Viewer Zero Footprint / ZFP-20025907, SA1005-Centricity Universal Viewer Zero Footprint / ZFP-00065849, SA2329-Centricity Universal Viewer Zero Footprint / ZFP-19678190, SA 1175-Centricity Universal Viewer Zero Footprint / ZFP-19719174, 2978539-Centricity Universal Viewer Zero Footprint / ZFP-19600952, SA2410-Centricity Universal Viewer Zero Footprint / ZFP-20025015, SA1304-Centricity Universal Viewer Zero Footprint / ZFP-02396452, SA 2385-Centricity Universal Viewer Zero Footprint / ZFP-20501423, SA2315-Centricity Universal Viewer Zero Footprint / ZFP-19669732, SA1006-Centricity Universal Viewer Zero Footprint / ZFP-02328482, SA 1176-Centricity Universal Viewer Zero Footprint / ZFP-19609918, SA1209-Centricity Universal Viewer Zero Footprint / ZFP-00066545, SA2235-Centricity Universal Viewer Zero Footprint / ZFP-19660083, SA2191-Centricity Universal Viewer Zero Footprint / ZFP-20617518, SA1054-Centricity Universal Viewer Zero Footprint / ZFP-19722888, SA 2281-Centricity Universal Viewer Zero Footprint / ZFP-18895618, SA2110-Centricity Universal Viewer Zero Footprint / ZFP-01805103, SA1008-Centricity Universal Viewer Zero Footprint / ZFP-00602579, SA1008-Centricity Universal Viewer Zero Footprint / ZFP-20620862, SA2645-Centricity Universal Viewer Zero Footprint / ZFP-21174755, SA2110-Centricity Universal Viewer Zero Footprint / ZFP-20999430, SA1008-Centricity Universal Viewer Zero Footprint / ZFP-21201005, SA 2393-Centricity Universal Viewer Zero Footprint / ZFP-19620146, SA2006-Centricity Universal Viewer Zero Footprint / ZFP-20019291, KTPH-Centricity Universal Viewer Zero Footprint / ZFP-01452994, 243134-Centricity Universal Viewer Zero Footprint / ZFP-19629976, 1363272-Centricity Universal Viewer Zero Footprint / ZFP-01286173, 9287622 - 2415034-Centricity Universal Viewer Zero Footprint / ZFP-02041820, NUH-SG-Centricity Universal Viewer Zero Footprint / ZFP-01476439, TTSH-RAD-Centricity Universal Viewer Zero Footprint / ZFP-01977001, 16723955-Centricity Universal Viewer Zero Footprint / ZFP-20685541, 16723955-Centricity Universal Viewer Zero Footprint / ZFP-20685543, 17006190-Centricity Universal Viewer Zero Footprint / ZFP-22258838, MPX431-Centricity Universal Viewer Zero Footprint / ZFP-01813942, FPD108-Centricity Universal Viewer Zero Footprint / ZFP-20084307, FPD108-Centricity Universal Viewer Zero Footprint / ZFP-20084312, GED649-Centricity Universal Viewer Zero Footprint / ZFP-19666476, GPX021-Centricity Universal Viewer Zero Footprint / ZFP-02041108, DEN272-Centricity Universal Viewer Zero Footprint / ZFP-01370312, DEN272-Centricity Universal Viewer Zero Footprint / ZFP-21287696, DE492A-Centricity Universal Viewer Zero Footprint / ZFP-19633836, NPV793-Centricity Universal Viewer Zero Footprint / ZFP-19672387, 150080-Centricity Universal Viewer Zero Footprint / ZFP-01299636, 492861-Centricity Universal Viewer Zero Footprint / ZFP-02248288, 437918-Centricity Universal Viewer Zero Footprint / ZFP-00163452, 722050-Centricity Universal Viewer Zero Footprint / ZFP-00555881, 0853550429-Centricity Universal Viewer Zero Footprint / ZFP-02041927, 0853550209-Centricity Universal Viewer Zero Footprint / ZFP-02093686, 0853550675-Centricity Universal Viewer Zero Footprint / ZFP-01287925, 0853550199-Centricity Universal Viewer Zero Footprint / ZFP-02093677, 0853550804-Centricity Universal Viewer Zero Footprint / ZFP-01286189, 0853550198-Centricity Universal Viewer Zero Footprint / ZFP-02093675, 0853550198-Centricity Universal Viewer Zero Footprint / ZFP-20541728, 0853551073-Centricity Universal Viewer Zero Footprint / ZFP-19622953, 0853550185-Centricity Universal Viewer Zero Footprint / ZFP-02093535, 0853550993-Centricity Universal Viewer Zero Footprint / ZFP-02093449, 0853551064-Centricity Universal Viewer Zero Footprint / ZFP-17533740, 0853550200-Centricity Universal Viewer Zero Footprint / ZFP-02093882, 0853550200-Centricity Universal Viewer Zero Footprint / ZFP-20541715, 0853550312-Centricity Universal Viewer Zero Footprint / ZFP-01286591, 0853550201-Centricity Universal Viewer Zero Footprint / ZFP-02093879, 0853550201-Centricity Universal Viewer Zero Footprint / ZFP-20541705, 0853550616-Centricity Universal Viewer Zero Footprint / ZFP-20912105, 0853550218-Centricity Universal Viewer Zero Footprint / ZFP-02093540, 0853550218-Centricity Universal Viewer Zero Footprint / ZFP-17533749, 81188-Centricity Universal Viewer Zero Footprint / ZFP-18227246, 6002-Centricity Universal Viewer Zero Footprint / ZFP-00158571, 34365-Centricity Universal Viewer Zero Footprint / ZFP-14374646, 34225-Centricity Universal Viewer Zero Footprint / ZFP-00157020, 486961-Centricity Universal Viewer Zero Footprint / ZFP-20611232, RXQ50-Centricity Universal Viewer Zero Footprint / ZFP-00505094, RXQ50-Centricity Universal Viewer Zero Footprint / ZFP-01701456, 50158-Centricity Universal Viewer Zero Footprint / ZFP-01981985, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 81564-Centricity Universal Viewer Zero Footprint / ZFP-00436804, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231, 446860-Centricity Universal Viewer Zero Footprint / ZFP-22255231 |
| FEI Number |
3004526608
|
Recalling Firm/ Manufacturer |
GE Healthcare 500 W Monroe St Chicago IL 60661-3671
|
| For Additional Information Contact | GE HealthCare Service 800-437-1171 |
Manufacturer Reason for Recall | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers.
" Internet Explorer 10 (IE10)
" Internet Explorer 11 (IE11)
" Firefox. |
FDA Determined Cause 2 | Software Design Change |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 07/23/2023 via letter. The notice explained the issue, potential risk to the patient, and provided the following actions be taken:
"You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions below.
Follow one of the below recommendations to ensure the latest addendum is being reviewed:
1. Use Microsoft Edge or Google Chrome browsers when launching ZFP Viewer.
OR
2. If you cannot use the browsers listed in #1, to find the addendum / latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.3.3 of The Series Selector, with subheading as Open a report/document using series selector"."
GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction.
For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity in Commerce | 803 units |
| Distribution | Worldwide distribution. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LLZ
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