Olympus TJF-Q180V flexible gastrointestinal recall
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system…
Why was Olympus TJF-Q180V flexible gastrointestinal recalled?
Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
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?
all codes
- Product
- Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 4436
- Distribution
- US Nationwide Distribution except PR
- Recall date
- February 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)