Reported May 6, 2020 · Completed
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
- Lot codes and dates
- Polaris 2.10 software version (disk batch 629774); iLab Polaris Systems affected
- product listing (serial numbers)
207 of 207 codes
20020420020920021720030820031020044820045020045620045720045820046120048020048120010320014520004420011820036020049820017083611031210443105487402839784978498850885168522852385301004410053102751027810362103651049610500105651056610604106511066710694107531077010867108721087310875108761095284757402839784978498
- Amount recalled
- 150 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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