Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iLab Polaris Multi-Modality Guidance System Recalled by Boston Scientific Corporation Due to Certain iLab Polaris Systems which were upgraded with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Quantity: 150 units
Why Was This Recalled?
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.
Where Was This Sold?
OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report