Recall Z-2029-2024 ยท HIH Hysteroscope (And Accessories)
Olympus Corporation of the Americas
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
| Date | Jun 6, 2024 (initiated Apr 18, 2024) |
| Status | Open, Classified |
| Reason | The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image. |
| Root cause | Process change control |
| Action | On May 9, 2024, URGENT: MEDICAL DEVICE REMOVAL letters were sent to the consignee. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device with serial number. 3. Please contact Customer Service at at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus, and we will replace this device a |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K897003 | OLYMPUS HYSTERORESECTOSCOPE Olympus Corp., Mar 16, 1990 |