Colonovideoscope recall
Colonovideoscope Model CF-H180AL
Why was Colonovideoscope recalled?
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
What should I do if I have this product?
Review the official FDA enforcement record for current 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: 04953170339615 Serial number: 2501131
- Product
- Colonovideoscope Model CF-H180AL
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of KY.
- Recall date
- June 29, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)