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Boston Scientific Corporation recalls iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Recalled May 6, 2020 · FDA recall Z-1804-2020 · Boston Scientific
Hazard
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. · FDA Class II
Units
150 units
Sold at
OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain. No U.S. consignees.
Description
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.
Product
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →