Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.

Recall details

Manufacturer

Boston Scientific Corporation

Distributor

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, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Faroe Islands, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Madagascar, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Yemen, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan R.O.C., Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, Uruguay, Venezuela, Vietnam, and Zimbabwe.

Lot

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, 00802526484803, 00802526486081, 00802526486937, 00802526497629, 00802526515927, 00802526532832, 00802526557002, 00802526565427, 00802526582301, 00802526587405, 00802526602924, 00802526606359, 00802526612442, 00802526445262, 00802526454950, 00802526474170, 00802526475474, 00802526475771, 00802526480652, 00802526486944, 00802526497643, 00802526517174, 00802526526817, 00802526527623, 00802526557019, 00802526565304, 00802526579929, 00802526583803, 00802526602931, 00802526605468, 00802526606304, 00802526612411, 00802526615627, 00802526442827, 00802526444807, 00802526469374, 00802526477683, 00802526482267, 00802526497650, 00802526517198, 00802526540400, 00802526555169, 00802526564826, 00802526582325, 00802526585104, 00802526586316, 00802526586316, 00802526603013, 00802526606328, 00802526612435, 00802526615429, 00802526474057, 00802526477522, 00802526479649, 00802526482274, 00802526486470, 00802526497667, 00802526517211, 00802526540509, 00802526555206, 00802526564833, 00802526582318, 00802526585111, 00802526586408, 00802526603006, 00802526605420, 00802526606335, 00802526612404, 00802526615504, 00802526480669, 00802526605451, 00802526496653, 00802526526824, 00802526527630, 00802526527630, 00802526564840, 00802526581038, 00802526582035, 00802526584602, 00802526582035, 00802526605451, 00802526606403, and 00802526612459.

Risk classification

Class II

Area (FDA)

device

Country

United States