Recall Z-1132-2023 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Olympus Corporation of the Americas
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
| Date | Feb 13, 2023 (initiated Dec 21, 2022) |
| Status | Open, Classified |
| Reason | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination |
| Root cause | Process design |
| Action | Olympus issued Urgent Field Safety Notice communication for the customers without the device on December 21, 2022 via FedEx 2-day delivery.. Letter states reason for recall, health risk and requires the following action: Although the device is no longer in your possession, Olympus requires you to take the following action: 1. Evaluate the situation according to your hospital procedures to determine if additional actions, including patient notification and/or clinical follow up, may be required. 2. Review affected patient records and report any potentially related adverse events (such as infec |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100584 | EVIS EXERAII 180 SYSTEM Olympus Medical Systems Corporation, Jul 2, 2010 |