Brand Name: EVIS EXERA III Gastrointestinal Videoscope recall
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version…
Why was Brand Name: EVIS EXERA III Gastrointestinal Videoscope 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.
- Product
- Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1749 units
- Distribution
- Domestic: US Nationwide Distribution.
- Recall date
- November 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)