Reported Nov 27, 2024 · Ongoing
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog…
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?
- Brand NameEVIS EXERA III Gastrointestinal
- Videoscope GIF-1TH190 Product NameOlympus
- GIF-1TH190 Model/Catalog NumberGIF-1TH190
- Software VersionN/A
- Product DescriptionThis instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery
- Lot codes and dates
- ModelGIF-1TH190
- UDI-DI
04953170343360Serial #: Less than 2446103
- Amount recalled
- 1749 units
Where it was sold
- Nationwide
Why it was recalled
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
This product could cause temporary or reversible health problems — stop using it.
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