Reported Oct 30, 2024 · Ongoing
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Olympus Corporation of the Americas
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: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Olympus Gastrointestinal Videoscope
- Model/Catalog NumberGIF-1100
- Lot codes and dates
- UDI-DI04953170420191
- Serial Numbes
1,407 of 1,407 codes
230404924045512404550240454124045372404577240457624045742404571240457024045692404568240456724045662404565240456424045632404562240456124045602404559240455224045472404626240462524046242404623240462024046192404618240461724046162404615240461424046132404612240461124046102404609240460824046072404606240460524046042404603240460124045992404598240460224046002404597240459624045952404594240459224045912404590240458924045882404587
- Amount recalled
- 1407 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
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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