Reported Jan 17, 2024 · Ongoing
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used
- for the following pacemaker productsALTRUA 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
- Lot codes and dates
- 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
143 of 143 codes
008025264354300080252646858200802526479663008025264806380080252648690600802526478246008025264796700080252648460500802526486913008025264966080080252649661500802526506703008025265159030080252651711200802526526602008025265276090080252655480300802526561900008025265648020080252657480100802526579905008025265820110080252660291700802526605406008025266063420080252661130800802526615603008025264374580080252644197400802526444814008025264672880080252646934300802526475450008025264757570080252647766900802526478253008025264796870080252648461200802526486920008025264966220080252649663900802526515910008025265171360080252652680000802526527616008025265548100080252656481900802526574818008025265810210080252658202800802526605437008025266063110080252661242800802526615634008025264543010080252646729500802526469350008025264754670080252647576400802526477676
- Amount recalled
- 14,328 ZOOM programmers
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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