The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Reason for recall: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s. Distribution: Distribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin Islands. There was also government/military distribution. Foreign distribution was made to Andorra, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, British Virgin Islands, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, Chin Quantity: 14,328 ZOOM programmers Lot/code info: All serial numbers. GTIN numbers in the U.S.: 00802526434723, 00802526456961, 00802526467653, 00802526468582, 00802526473449, 00802526474859, 00802526475788, 00802526477676, 00802526478239, 00802526479663, 00802526480638, 00802526484599, 00802526486906, 00802526494406, 00802526497605, 00802526516009, 00802526523212, 00802526535406, 00802526554209, 00802526562600, 00802526564703, 00802526575303, 00802526579707, 00802526582004, 00802526602900, 00802526604584, 00802526606366, 00802526606403, and 00802526611322. GTIN numbers OUS: 00802526435430, 00802526468582, 00802526479663, 00802526480638, 00802526486906, 00802526478246, 00802526479670, 00802526484605, 00802526486913, 00802526496608, 00802526496615, 00802526506703, 00802526515903, 00802526517112, 00802526526602, 00802526527609, 00802526554803, 00802526561900, 00802526564802, 00802526574801, 00802526579905, 00802526582011, 00802526602917, 00802526605406, 00802526606342, 00802526611308, 00802526615603, 00802526437458, 00802526441974, 00802526444814, 00802526467288, 00802526469343, 00802526475450, 00802526475757, 00802526477669, 00802526478253, 00802526479687, 00802526484612, 00802526486920, 00802526496622, 00802526496639, 00802526515910, 00802526517136, 00802526526800, 00802526527616, 00802526554810, 00802526564819, 00802526574818, 00802526581021, 00802526582028, 00802526605437, 00802526606311, 00802526612428, 00802526615634, 00802526454301, 00802526467295, 00802526469350, 00802526475467, 00802526475764, 00802526477676, 00802526
00802526434723, 00802526456961, 00802526467653, 00802526468582, 00802526473449, 00802526474859, 00802526475788, 00802526477676, 00802526478239, 00802526479663, 00802526480638, 00802526484599, 00802526486906, 00802526494406, 00802526497605, 00802526516009, 00802526523212, 00802526535406, 00802526554209, 00802526562600, 00802526564703, 00802526575303, 00802526579707, 00802526582004, 00802526602900, 00802526604584, 00802526606366, 00802526606403, 00802526611322, 00802526435430, 00802526478246, 00802526479670, 00802526484605, 00802526486913, 00802526496608, 00802526496615, 00802526506703, 00802526515903, 00802526517112, 00802526526602
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.