| |
Class 1 Device Recall GE |
 |
| Date Initiated by Firm |
December 19, 2022 |
| Date Posted |
February 08, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1053-2023 |
| Recall Event ID |
91456 |
| 510(K)Number |
K093514
|
| Product Classification |
System, tomography, computed, emission - Product Code KPS
|
| Product |
GE Nuclear Medicine 600/800 series systems, specifically:
a) 870,
b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA,
c) 870 DR / Dismount,
d) 870 DR / Dismount / 60HZ,
e) 870 DR 3/8 inch WSO,
f) 870 DR 3/8 inch NM Gantry,
g) 870 DR 3/8 inch,
h) 870 DR 3/8 inch CH,
i) 870 DR 5/8 inch NM GANTRY,
j) 870 DR BJ / Dismount,
k) 870 DR CyberDefense 3/8 inch NM Gantry,
l) 870 DR NM GANTRY FINAL - NEW ROTOR,
m) 870 DR China,
n) D670 NM GANTRY WITH NEW ROTOR,
o) D670 DR 3/8 inch 16 SL,
p) D670 DR 3/8 inch MEA,
q) D670 DR 3/8 inch,
r) D670 DR 3/8 inch 16SL,
s) D670 DR 3/8 inch 16SL NR,
t) D670 DR 3/8 inch BJ,
u) D670 DR 3/8 inch MEA,
v) D670 DR NM Gantry 3/8 inch,
w) D670 DR NM Gantry 5/8 inch,
x) D670 DR with new rotor,
y) D670 ES NM Gantry 3/8 inch,
z) D670 ES NM/CT 3/8 inch O540+ NM Gantry,
aa) D670 ES NM/CT DR 3/8 inch,
bb) D670 GANTRY,
cc) D670 PRO NM Gantry 3/8 inch,
dd) D670 PRO NM GANTRY 3/8 inch,
ee) DISC NM/CT670 DR 3/8 inch,
ff) DISC NM/CT870 DR 3/8 inch,
gg) DISC NM/CT870 DR 3/8 inch,
hh) DISC NM/CT870 DR 5/8 inch,
ii) DISCOVERY 670 (TANDEM),
jj) DISCOVERY NM 670,
kk) DISCOVERY NM/CT 670 3/8 inch PRO,
ll) DISCOVERY NM/CT 670 3/8 inch PRO NR,
mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS,
nn) NM/CT 870 DR,
oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE,
pp) NM/CT 870 DR 3/8 inch WSO,
qq) NM/CT 870 DR O540 3/8 inch,
rr) NM/CT 870 DR O540 3/8 inch BJ,
ss) NM/CT 870 DR O540 5/8 inch,
tt) NM/CT 870 ES 3/8 inch,
uu) NM/CT 870DR China for China,
vv) NM/CT870 DR 3/8 inch O540,
ww) NM/CT D870 DR O540 3/8 inch,
xx) TANDEM DISCOVERY 670 INT;
Emission Computed Tomography System
|
| Code Information |
a) 870: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2200004, NT3DG2200009, NT3DG2200018, NT3DG2200002;
b) 870 DR 3/8" NM GANTRY WITH NEW ROTOR - MEA: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2100018BH;
c) 870 DR / Dismount: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100006;
d) 870 DR / Dismount / 60HZ: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2000016BH;
e) 870 DR 3/8" WSO: Catalog number H3906EM, UDI/DI Not Applicable, Serial Numbers: 870B64224, 870Z64148;
f) 870 DR 3/8" NM Gantry: Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870Y64064, 870Y64040, 870A64172, 870Z64145, 870A64161, 870Z64111, 870Z64126, 870Y64081, 870A64210, 870X64003, 870A64180, 870Y64047, 870Y64044, 870Y64079, 870Y64050, 870Z64130, 870X64011, 870Y64095, 870Y64037, 870Y64074, 870Y64067, 870Y64051, 870A64162, 870X64024, 870A64163, 870A64165, 870X64002, 870Y64072, 870Z64107, 870Z64108, 870X64032, 870A64192, 870A64183, 870A64164, 870B64229, 870A64176, 870A64185, 870Z64137, 870Z64117, 870X64001, 870Y64055, 870Y64088, 870B64235, 870Y64078, 870Y64080, 870Z64125, 870Z64098, 870A64204, 870A64205, 870B64306, 870B64305, 870A64182, 870B64261, 870Y64069, 870Z64104, 870Y64042, 870Y64039, 870Y64086, 870Z64146, 870A64179, 870Y64085, 870A64168, 870Z64103, 870Y64094, 870Z64101, 870A64160, 870B64300, 870Y64046, 870B64302, 870A64199, 870Y64056, 870Z64121, 870A64174, 870X64004, 870X64012, 870X64007, 870Y64048, 870X64009, 870Z64124, 870X64026, 870Z64119, 870Z64122, 870Y64049, 870Y64089, 00000870Y64035, 870Z64134, 870Y64052, 870Y64076, 870Y64063, 870A64159, 870Z64133, 870B64286, 870B64247, 870B64244, 870A64184, 870B64240, 870B64264, 870B64287, 870A64196, 870A64187, 870B64307, 870A64208, 87EB77017, 870X64016, 870X64005, 870Z64136, 870Y64033, 870A64153, 870A64154, 870B64227, 870Y64091, 870B64231, 870B64292, 870Z64149, 87EA77011, 870X64022, 870Y64053, 870Z64114, 870Z64115, 87EZ77003, 87EB77016, 87EZ77004, 870B64233, 870Z64141, 87EB77014, 870A64175, 87EB77015, 870X64019, 870A64188, 870Y64059, 870Y64068, 870Y64071, 870Y64082, 870B64265, 870Z64102, 870X64020, 870Y64090, 870B64262, 870B64274, 870B64268, 870B64275, 870Z64128, 870B64270, 870B64271, 870B64272, 870B64273, 870B64266, 870B64280, 870B64267, 870Z64116, 870B64276, 870B64277, 870B64278, 870B64279, 870B64269, 870B64281, 870B64282, 870B64283, 870Z64142, 870Y64065, 870A64158, 870X64025, 87EZ77001, 870Z64120, 870Y64038, 870B64236, 870Y64077, 870A64202, 870A64207, 870B64251, 870B64221, 870A64197, 870X64010, 870Y64073, 870Y64036, 870Y64092, 870Y64087, 870X64027, 870X64029, 870Y64084, 870X64030, 870X64023, 870X64028, 87EA77010, 87EA77012, 870B64222, 870A64155, 870B64226, 870B64225, 87EB77018, 870B64297, 870B64299, 870B64293, 87EB77019, 870B64258, 870A64209, 87EZ77007, 870B64253, 870A64217, 870Z64127, 870B64285, 870Y64083, 870B64257, 870B64259, 870X64013, 870B64252, 870Z64105, 870Y64061, 870B64284, 870B64254, 870B64260, 870B64308, 870B64296, 870B64303, 870Z64110, 870Z64144, 870Y64075, 870A64171, 870A64215, 870A64212, 870Z64129, 870X64021, 870A64198, 870B64230, 870Z64113, 870Z64131, 870Z64132, 870Y64070, 870Z64140, 870B64263, 870B64294, 870A64190, 870Y64058, 870B64241, 870Z64135, 870Y64097, 870Z64099, 870Z64151, 870Y64057, 870A64157, 870B64242, 870B64243, 870B64250, 870Z64109, 870B64237, 870Z64106, 870A64173, 870X64008, 870A64152, 870B64218, 870B64234, 870B64238, 870B64239, 870A64200;
g) 870 DR 3/8": Catalog number H3100AP, UDI/DI Not Applicable, Serial Numbers: 870Y64034; UDI/DI 010084068214083621870X6401511180900, Serial Numbers: 870X64015;
h) 870 DR 3/8" CH: Catalog number H2402AG, UDI/DI To be provided, Serial Numbers: NT3DG1900005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1800002BH;
i) 870 DR 5/8" NM GANTRY: Catalog number H3100Q, UDI/DI 010084068214083621870X6401811181000, Serial Numbers: 870X64017; UDI/DI 010084068214083621870Y6406611190700, Serial Numbers: 870Y64066; UDI/DI Not Applicable, Serial Numbers: 870Y64045, 870A64201, 00000870X64014, 870Y64041;
j) 870 DR BJ / Dismount: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG1900013BH;
k) 870 DR CyberDefense 3/8" NM Gantry: Catalog number H3906FF, UDI/DI Not Applicable, Serial Numbers: 87CA83004, 87CA83001; , UDI/DI To be provided, Serial Numbers: 87CA83002, 87ZA83005;
l) 870 DR NM GANTRY FINAL - NEW ROTOR: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870B64288, 00000870Z64139;
m) 870 DR China: Catalog number To be provided, UDI/DI To be provided, Serial Numbers: NT3DG2100016BH;
n) D670 NM GANTRY WITH NEW ROTOR: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870A64203, 87EA77013, 870B64255;
o) D670 DR 3/8" 16 SL: Catalog number 5791566, UDI/DI To be provided, Serial Numbers: DRGY56031, DRGY56025; UDI/DI Not Applicable, Serial Numbers: 00000DRGZ56044;
Catalog number H3100BT, UDI/DI To be provided, Serial Numbers: 00000DRGX56017, 00000DRGZ56042; UDI/DI 010084068213935921DRGY5603011190700, Serial Numbers: DRGY56030;
p) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG1900005BH;
q) D670 DR 3/8": Catalog number H3100AK, UDI/DI Not Applicable, Serial Numbers: 00000589470GE4;
r) D670 DR 3/8" 16SL: Catalog number 5791566, UDI/DI Not Applicable, Serial Numbers: DRGY56024; Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGY56026, DRGX56023, DRGX56009, DRGZ56047, DRGZ56049, DRGZ56045, DRGZ56051, DRGZ56056, DRGZ56046;
s) D670 DR 3/8" 16SL NR: Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGZ56050;
t) D670 DR 3/8" BJ: Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1800002BH, UDI/DI 01008406821393111119030021NT2RG1900001BH, Serial Numbers: NT2RG1900001BH;
u) D670 DR 3/8" MEA: Catalog number 5376204-70-61-1, UDI/DI To be provided, Serial Numbers: NT2RG2200001BH;
v) D670 DR NM Gantry 3/8": Catalog number H3100BT, UDI/DI Not Applicable, Serial Numbers: DRGX56002, DRGY56028, DRGX56005, DRGY56033, DRGX56004, DRGY56037, DRGX56003, DRGX56008, DRGX56007, DRGY56033, DRGZ56039, DRGX56011, DRGX56006, DRGX56021, DRGZ56054, DRGZ56040, DRGY56038, DRGY56032, DRGX56019, DRGZ56052, DRGX56012, DRGY56029, DRGY56027, DRGZ56048, DRGX56014, DRGZ56053, DRGZ56055, DRGY56034, DRGX56020, DRGX56016, DRGY56036, DRGX56022, DRGX56015, DRGZ56041; UDI/DI To be provided, Serial Numbers: DRGX56018, DRGA56057, DRGA56058; UDI/DI 010084068213935921DRGY5603511190900, Serial Numbers: DRGY56035; UDI/DI 010084068213935921DRGZ5604311200400, Serial Numbers: DRGZ56043;
w) D670 DR NM Gantry 5/8": Catalog number H3100CM, UDI/DI Not Applicable, Serial Numbers: DRGX56010;
x) D670 DR with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2RG1900003, NT2RG2000001BH;
y) D670 ES NM Gantry 3/8": Catalog number H3100XF, UDI/DI Not Applicable, Serial Numbers: ESGY53002, ESGY53001, ESGY53003, ESGZ53005, ESGA53008, ESGB53011, ESGZ53004, ESGA53007, ESGZ53006, ESGA53010, ESGA53009;
z) D670 ES NM/CT 3/8" O540+ NM Gantry,
aa) D670 ES NM/CT DR 3/8": Catalog number H3100BM, UDI/DI Not Applicable, Serial Numbers: ESPX54001, ESPY54002;
bb) D670 GANTRY: Catalog number H3100BM , UDI/DI Not Applicable, Serial Numbers: ESPY54003;
cc) D670 PRO NM Gantry 3/8": Catalog number H3100NC, UDI/DI UDI Not Required, Serial Numbers: 21128;
dd) D670 PRO NM GANTRY 3/8": Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52045, PRGY52027, PRGA52061, PRGY52021, PRGY52023, PRGY52018, PRGZ52057, PRGY52013, PRGZ52048, PRGY52020, PRGZ52058, PRGX52008, PRGZ52046, PRGA52063, PRGA52068, PRGX52007, PRGZ52047, PRGZ52059, PRGA52066, PRGA52070, PRGY52039, PRGY52012, PRGZ52051, PRGX52004, PRGZ52055, PRGY52016, PRGX52009, PRGY52015, PRGZ52054, PRGY52031, PRGY52036, PRGY52024, PRGY52028, PRGY52025, PRGY52037, PRGY52032, PRGY52029, PRGZ52050, PRGX52005, PRGA52064, PRGY52030, PRGZ52056, PRGA52069, PRGX52002, PRGX52006, PRGX52003, PRGA52060; , UDI/DI UDI_Not_Required_2, Serial Numbers: PRGY52035; , UDI/DI To be provided, Serial Numbers: PRGA52077, PRGA52072, PRGA52073, PRGA52075, PRGB52083, PRGA52076, PRGA52079, PRGB52080, PRGB52081, PRGB52082, PRGA52071, PRGA52074, PRGB52084, PRGA52078; UDI/DI 010084068213937321PRGX5200111180700, Serial Numbers: PRGX52001; UDI/DI 010084068213937321PRGX5201011181200, Serial Numbers: PRGX52010; UDI/DI 010084068213937321PRGY5201111190100, Serial Numbers: PRGY52011; UDI/DI 010084068213937321PRGY5201711190300, Serial Numbers: PRGY52017;
ee) DISC NM/CT670 DR 3/8": Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT2RG1900002BH; UDI/DI To be provided, Serial Numbers: T2RG1900004BH;
ff) DISC NM/CT870 DR 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EA77009, 870A64177, 870A64156, 870Y64043, 870Z64112, 870Z64150; UDI/DI UDI Not Required, Serial Numbers: 870Y64096; UDI/DI To be provided, Serial Numbers: 870B64304, 00000870Z64147, 870Y64093, 870B64245;
gg) DISC NM/CT870 DR 5/8": Catalog number 5791566, UDI/DI To be provided, Serial Numbers: 870X64018;
hh) DISCOVERY 670 (TANDEM): Catalog number H3100XB , UDI/DI To be provided , Serial Numbers: PRGZ52040;
ii) DISCOVERY NM 670: Catalog number 5474053, UDI/DI To be provided, Serial Numbers: 27053;
kk) DISCOVERY NM/CT 670 3/8" PRO: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGZ52044, PRGA52065, PRGY52033, PRGZ52041, PRGZ52043, PRGZ52052, PRGY52026, PRGY52022, PRGY52014, PRGA52067, PRGY52034, PRGA52062; UDI/DI UDI_Not_Required_2, Serial Numbers: PRGZ52049, PRGZ52042; UDI/DI To be provided, Serial Numbers: PRGY52019;
ll) DISCOVERY NM/CT 670 3/8" PRO NR,
mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 00000870Y64060;
nn) NM/CT 870 DR: Catalog number H3100AS , UDI/DI To be provided, Serial Numbers: 87EZ77008;
oo) NM/CT 870 DR 3/8" CYBER DEFENCE: Catalog number H3906FF, UDI/DI To be provided, Serial Numbers: 87ZB83006, 87CA83003;
pp) NM/CT 870 DR 3/8" WSO: Catalog number H3100AS, UDI/DI To be provided, Serial Numbers: 870A64189, 870A64216, 870B64228, 870B64220, 870B64223, 870A64181, 870A64211, 870A64213, 870B64249; Catalog number 5376204-70-60, UDI/DI 010084068214083621870A6421411211100, Serial Numbers: 870A64214; UDI/DI 010084068214083621870A6419511210900, Serial Numbers: 870A64195; UDI/DI 010084068214083621870A6419411210800, Serial Numbers: 870A64194; UDI/DI 010084068214083621870B6425611220500, Serial Numbers: 870B64256; UDI/DI 010084068214083621870A6419311210800, Serial Numbers: 870A64193; UDI/DI 010084068214083621870B6423211220200, Serial Numbers: 870B64232; UDI/DI 010084068214083621870B6424611220300, Serial Numbers: 870B64246; UDI/DI 010084068214083621870B6424811220300, Serial Numbers: 870B64248; UDI/DI 010084068214083621870A6419111210800, Serial Numbers: 870A64191; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870B64295;
qq)NM/CT 870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900012BH, NT3DG2000001BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200013BH; Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 870X64031, 87EZ77006, 87EZ77005, 870Z64143, 870Y64062, 870Z64123, 870Z64118, 870A64169, 870A64166; : Catalog number To be provided, UDI/DI 010084068214083621870B6429111221100, Serial Numbers: 870B64291; Catalog number To be provided, UDI/DI 010084068214083621870B6430111221100, Serial Numbers: 870B64301;
rr) NM/CT 870 DR O540 3/8" BJ: Catalog number 5376204-70-60-1, UDI/DI 01008406821421201121050621NT3DG2100005BH, Serial Numbers: NT3DG2100005BH; UDI/DI Not Applicable, Serial Numbers: NT3DG1900014BH, NT3DG1900015BH, NT3DG2100010BH, NT3DG2100007BH, NT3DG2200005BH, NT3DG1900002BH, NT3DG2100011BH, NT3DG2200003BH, NT3DG2200014BH, NT3DG2000012BH, NT3DG1900001BH, NT3DG1800001BH, NT3DG2100003BH, NT3DG2200007BH, NT3DG2100001BH, NT3DG2100012BH, NT3DG2100008BH; UDI/DI To be provided, Serial Numbers: NT3DG1900009BH, NT3DG2200004BH, NT3DG2000013BH, NT3DG1900006BH, NT3DG2100002BH, NT3DG1900004BH, NT3DG1900011BH, NT3DG2100013BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200019BH, NT3DG2000003BH, NT3DG2000005BH, NT3DG2000006BH; : Catalog number To be provided, UDI/DI Not Applicable , Serial Numbers: NT3DG2000004BH, NT3DG2200011BH, NT3DG2200017BH, NT3DG2000014BH;
ss) NM/CT 870 DR O540 5/8": Catalog number H3100Q, UDI/DI Not Applicable, Serial Numbers: 870A64170; Catalog number 5791566, UDI/DI Not Applicable , Serial Numbers: 870Z64138, 870B64219;
tt) NM/CT 870 ES 3/8": Catalog number H3100AS, UDI/DI Not Applicable, Serial Numbers: 87EZ77002;
uu) NM/CT 870DR China for China: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200010BH; NT3DG2200015BH, NT3DG2100015BH, NT3DG2200006BH, NT3DG2200001BH; : Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200016BH, NT3DG2200012BH;
vv) NM/CT 870 DR 3/8" O540: Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2000008BH, NT3DG2000010BH, NT3DG2000011BH, NT3DG2100009BH, NT3DG2100014BH, NT3DG2100004BH; Catalog number 5376204-70-61-1, UDI/DI Not Applicable, Serial Numbers: NT3DG2200008BH
ww) NM/CT D870 DR O540 3/8": Catalog number 5376204-70-60-1, UDI/DI Not Applicable, Serial Numbers: NT3DG1900010BH, NT3DG1900003BH, NT3DG2000015BH; Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT3DG2000002BH; Catalog number To be provided, UDI/DI To be provided, Serial Numbers: 870A64186;
xx) TANDEM DISCOVERY 670 INT: Catalog number H3100XB, UDI/DI Not Applicable, Serial Numbers: PRGY52038. |
Recalling Firm/
Manufacturer |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
4, Hayozma St
Tirat Carmel Israel
|
| For Additional Information Contact |
GE HealthCare Service
800-4371171
|
Manufacturer Reason
for Recall |
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
|
FDA Determined
Cause 2 |
Process control |
| Action |
GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken:
.GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your
system is listed in the Affected Product Details and Appendix of this letter, until an
inspection of your system is completed by GE Healthcare and you have been
provided with a letter indicating the system can be returned to clinical use.
.GE Healthcare will correct all affected products at no cost to you. GE Healthcare
will inspect your system to ensure that the appropriate mitigation is correctly
implemented to address this potential life-threatening concern. A GE Healthcare
representative will contact you to arrange for this correction.
.If you have any questions or concerns regarding this notification, please contact
GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
|
| Quantity in Commerce |
557 units |
| Distribution |
Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam. |
| 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.
|
| 510(K) Database |
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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