EVIS EXERA II Gastrointestinal Videoscope-indicated for recall
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model…
Why was EVIS EXERA II Gastrointestinal Videoscope-indicated for recalled?
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
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?
UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545
- Product
- EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of AL, FL, NC, NY.
- Recall date
- June 29, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)