FDA Recall
Terminated
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Recall: Z-1009-2019
·
Initiated December 17, 2018
Recall
- Recall Number
- Z-1009-2019
- Event Number
- 82099
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- NWB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 17, 2018
- Terminated
- November 18, 2020
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610
Description
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Reason
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Action
Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Distribution
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Quantity
2