Boston Scientific recalls 3120 ZOOM LATITUDE PRM devices with Model 2892 software that display incorrect 1990s dates on pacemaker diagnostics. Affected units include specific pacemaker models and GTIN numbers. No action needed as software error does not cause harm.
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.
Boston Scientific is recalling certain pacemaker programmers that show diagnostic dates in the 1990s instead of the correct year. This software error does not cause harm but may confuse users about the device's age or maintenance needs.
The software displays diagnostic dates with a year in the 1990s instead of the correct year. This error is a display issue that does not affect device function or cause harm to users.
Pacemaker owners using Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) with Model 2892 software. Most at risk are users of specific pacemaker models like ALTRUA 20, INSIGNIA I Entra, and NEXUS I Plus.
Check if your pacemaker programmer shows diagnostic dates in the 1990s. Affected units include Boston Scientific Model 3120 ZOOM LATITUDE PRM installed with Model 2892 software and specific pacemaker models listed in the recall.
Look for diagnostic dates showing a year in the 1990s on the pacemaker programmer.
No, the software error only displays incorrect dates and does not affect device function or cause harm.
Affected pacemaker models include ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.
No action is needed as the software error does not cause harm. Users can continue using the device normally.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0673-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0673-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.