Boston Scientific recalls iLab Polaris Multi-Modality Guidance Systems with specific software versions due to a bug that prevents proper archiving of Diastolic Hyperemia-Free Ratio data.
Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.
Boston Scientific is recalling certain iLab Polaris Multi-Modality Guidance Systems and iLab Ultrasound Imaging Systems that were upgraded with a 2.10 software version (disk batch 629774). This software version has a bug that causes Diastolic Hyperemia-Free Ratio data to not be archived when using specific image formats, potentially leading to missed medical data.
The software bug causes the system to fail to archive Diastolic Hyperemia-Free Ratio data when using Multi-Frame UltraSound or True Color Secondary Capture image formats. Users won't receive warnings about this issue, so critical medical data may be lost without their knowledge.
Medical professionals using the iLab Polaris systems with the specific software version (2.10, disk batch 629774) are affected. Those who rely on accurate data archiving for medical diagnostics are at the highest risk.
Check if your iLab Polaris system has software version 2.10 (disk batch 629774). Affected units have specific serial numbers listed in the recall notice.
Verify your system's software version by checking the disk batch number. If it is 629774, the system is affected.
The affected software version is 2.10 (disk batch 629774).
Check the serial number against the list of affected units provided in the recall notice.
The recall record does not mention any remedy or fix for this software bug.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1804-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1804-2020 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.
