EVIS EXERA III Gastrointestinal Videoscope
Recall
- Recall Number
- Z-0288-2024
- Event Number
- 93212
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- FDF
- Status
- Open, Classified
- Root Cause
- Reprocessing Controls
- Initiated
- October 2, 2023
- Posted
- November 9, 2023
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
EVIS EXERA III Gastrointestinal Videoscope
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to [email protected] or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].
Nationwide Distribution.
1687 units