Recall Z-0288-2024 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
EVIS EXERA III Gastrointestinal Videoscope
| Date | Nov 9, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| Reason | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| Root cause | Reprocessing Controls |
| Action | 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 olympus5381@sedgwick.com 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 em |
| Quantity | 1687 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112680 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corporation, Feb 16, 2012 |