Boston Scientific recalls LATITUDE Model 3300 programming systems that may download unapproved software updates, potentially causing safety issues. Affected units have specific serial numbers.
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
Boston Scientific is recalling its LATITUDE Model 3300 programming systems because they may download unapproved software updates. This could pose safety risks if the software isn't approved by the FDA.
The programming system may download unapproved software updates that haven't been approved by the FDA. This could lead to safety issues if the software isn't properly vetted for clinical use.
Healthcare professionals using the LATITUDE Model 3300 programming systems in hospitals or clinics are likely affected. Those with the specific serial numbers listed are at risk.
Check if your LATITUDE Model 3300 programming system has one of the following serial numbers: 008885, 010823, 010615, 007886.
Identify if your LATITUDE Model 3300 has a serial number from the list: 008885, 010823, 010615, 007886.
Boston Scientific released a software update that directed the Model 3300 programmers to download unapproved software applications, which may pose safety risks.
Check if your LATITUDE Model 3300 has one of the listed serial numbers. If so, you should stop using it until you can contact Boston Scientific for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1511-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1511-2020 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.
