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U.S. Department of Health and Human Services

Class 2 Device Recall Ventri Discovery NM 530c

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  Class 2 Device Recall Ventri Discovery NM 530c see related information
Date Initiated by Firm January 09, 2013
Date Posting Updated April 24, 2013
Recall Status1 Terminated 3 on August 06, 2013
Recall Number Z-1168-2013
Recall Event ID 64694
510(K)Number K051855  K080124  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
Code Information Serial #, 19069, 19082, 19065, 19015, 19057, 19008, 19005, 19075, 19064, 19066, 19078, 19034, 19061, 19041, 19081, 19036, 19058, 16006, 19151, 19091, 16013, 19049, 19073, 19059, 19016, 0000000ME11041, 19027, 19062, 19012, 19030, 16001, 19097, 19072, 19035, 19043, 16014, 19032, 19020, 19022, 16004, 16009, 19053, 16008, 19093, 19004, 19029, 19076, 19050, 16002, 19019, 19006, 19038, 16005, 00000000VEN002, 11021, 0000000 VEN005, 11039, 11019, 11001, 11027, 11008, 11031, 11028, 11046, 11038, 11015, 11045, 11044, 11043, 11025, 11018, 11030, 11033, 11022, 11026, 11002, 11003, 11029, 11032, 11009, 11020, 11007, 00000000VEN003, 11010, 11037, 11013, 11005, 11041, 11040, 11006, 00000000VEN004, 11138, 11220, 11093, 11294, 11801, 11228, 11251, 11253, 11248, 11209, 11247, 11193, 11262, 11214, 11261, 11054, 11189, 11092, 11244, 11260, 11087, 11255, 11359, 11231, 11059, 11237, 11303, 11212, 11300, 11417, 11397, 11391, 11389, 11232, 11263, 11210, 11213, 11208, 11023, 11290, 11215, 11091, 11252, 11245, 11072, 11219, 11394, 11205, 11202, 11225, 11049, 11131, 11156, 11242, 11292, 11243, 11291, 11102, 11108, 11298, 11319, 11250, 11254, 11384, 11258, 11257, 11035, 11114, 000E3GT08064A6, 0000E3GT09163A, 0000E3GT08038A, 0000INDNVC0041, 0000E3GT10189A, 0000E3GT09136A, 11075, 11430, 11137, 11154, 11233, 11052, 11322, 11301, 11286, 11078, 11327, 11125, 11152, 11387, 11337, 11396, 11288, 11147, 11395, 11427, 11328, 11450, 11128, 11471, 11165, 11424, 11448, 11421, 11332, 11203, 11468, 11363, 11069, 11127, 11284, 11124, 11229, 11297, 11190, 11204, 11306, 11061, 11161, 11151, 11441, 11067, 11336, 11435, 11077, 11191, 11497, 11206, 11192, 11211, 11085, 11325, 11222, 11392, 11169, 11347, 11166, 11050, 11470, 11464, 11280, 11469, 11376, 11310, 11119, 11501, 11076, 11086, 11140, 11366, 11178, 11495, 11383, 11352, 11345, 11358, 11223, 11183, 11422, 11004, 11307, 11107, 11074, 11293, 11276, 11270, 11218, 11142, 11145, 11060, 11170, 11188, 11431, 11088, 11275, 11462, 11465, 11117, 11179, 11414, 11150, 11149, 11455, 11089, 11374, 11056, 11453, 11017, 11279, 11146, 11324, 11320, 11360, 11371, 11385, 11467, 11273, 11266, 11230, 11353, 11409, 11349, 11101, 11148, 11315, 11410, 11461, 11228, 11443, 11123, 11090, 11082, 11438, 11287, 11454, 11491, 11065, 11080, 11084, 11269, 11299, 11130, 11043, 11278, 11053, 11070, 11122, 11098, 11393, 11024, 11466, 11372, 11234, 11180, 11063, 11096, 11051, 11485, 11340, 11334, 11095, 11490, 11309, 11403, 11330, 11194, 11173, 11162, 11134, 11277, 11402, 11066, 11167, 11172, 11164, 11308, 11226, 11426, 11445, 11282, 11404, 11196, 11181, 11227, 11264, 11267, 11415, 11333, 11311, 11185, 11289, 11304, 11331, 11412, 11346, 11405, 11444, 11369, 11224, 11221, 11344, 11439, 11436, 11182, 11118, 11449, 11423, 11356, 11478, 11494, 11246, 11058, 11105, 11100, 11475, 11472, 11486, 11201, 11113, 11474, 11109, 11296, 11357, 11272, 11312, 11159, 11121, 11463, 11406, 11487, 11271, 11437, 11321, 11216, 11377, 11132, 11458, 11133, 11502, 11317, 11314, 11064, 11195, 11305, 11452, 11492, 11316, 11062, 11382, 11055, 11103, 11400, 11429, 11432, 11433, 11373, 11323, 11342, 11281, 11129, 11097, 11368, 11171, 11350, 11268, 11481, 11186, 11476, 11110, 11388, 11295, 11168, 11106, 11425, 11120, 11184, 11256, 11157, 11155, 11313, 11177, 11335, 11379, 11459, 11329, 11217, 11198, 11440, 11413, 11187, 11265, 1, 11338, 11199, 11362, 11083, 11200, 11259, 11381, 11016, 11380, 11408, 11111, 11285, 11135, 11480, 11354, 11428, 11401, 11447, 11163, 11411, 11416, 11446, 11160, 11419, 11384, 11249, 11238, 11240, 11141, 11241, 11434, 11483, 11456, 11274, 11207, 11375, 11035, 11114, 11115, 11318, 11339, 11048, 11176, 16017, 19098, 19070, 19086, 19044, 19083, 19056, 19048, 19009, 19040, 19002, 16007, 19080, 16020, 19026, 19025, 19024, 16019, 19052, 19047, 19003, 19007, 19001, 16015, 19042, 19100, 19017, 16010, 16011, 19063, 19037, 19011, 19095, 19092, 19094, 19077, 19067, 19039, 19021, 19023, 19031, 19084, 19013, 19028, 19088, 19046, 19014, 16016, 19085, 19068, 19033.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
FDA Determined
Cause 2
Device Design
Action Consignees were sent on 1/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated January 9, 2013. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology / Head of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
Quantity in Commerce 556
Distribution Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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