Recall Z-1559-2022 ยท EOQ Bronchoscope (Flexible Or Rigid)
Aizu Olympus Co., Ltd.
EVIS EXERA III Bronchovideoscope
| Date | Jul 20, 2022 |
| Status | Terminated |
| Reason | The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Field Safety Notice was distributed by the recalling firm on 07/20/2022 notifying consignees that a bronchoscope utilized in a veterinary endoscopy procedure was subsequently distributed as a service loaner in error. The device was utilized in a single procedure on a cat. Actions to be taken by customers include evaluating the situation according to hospital procedure to determine if patient notification or follow up may be required, review patient records and report any potentially adverse events to Olympus and FDA and acknowledge receipt of the recall notification by email or throu |
| Distribution | US Nationwide distribution in the states of FL, IL, NC, PA & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Olympus Medical Systems Corp., Jan 21, 2021 |