Reported May 5, 2021 · Terminated
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis,…
Boston Scientific Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- EXALT Controller - Product Usageintended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation
- UPNM00542430
- Lot codes and dates
- Serial Numbers2005201213 2005201287 2005201346
- GTIN08714729990901
- Amount recalled
- 3 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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