Boston Scientific is a leading global medical device company specializing in cardiovascular, neurovascular, and surgical products. They provide innovative solutions for healthcare professionals.
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Boston Scientific is a leading global medical device company that specializes in cardiovascular, neurovascular, and surgical products. They provide innovative solutions for healthcare professionals.
Low risk due to the company's focus on medical device safety and regulatory compliance.
Healthcare professionals, medical device users, and patients
Check for proper labeling, compliance with medical device regulations, and manufacturer recommendations.
Ensure the device is labeled with the correct manufacturer information and model number.
Verify that the device meets all applicable medical device regulations and standards.
Follow the manufacturer's instructions for use and maintenance.
Boston Scientific is a leading global medical device company that specializes in cardiovascular, neurovascular, and surgical products. They provide innovative solutions for healthcare professionals.
Yes, Boston Scientific products are designed and manufactured to meet strict safety and quality standards. They undergo rigorous testing and regulatory compliance checks.
Follow the manufacturer's instructions for use and maintenance. Always check the device label for the correct model number and ensure it is compatible with your medical procedures.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1671-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1671-2022 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.