Recall Z-0718-2024 ยท GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
| Date | Jan 12, 2024 (initiated Dec 4, 2023) |
| Status | Open, Classified |
| Reason | Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient). |
| Root cause | Under Investigation by firm |
| Action | On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com. |
| Quantity | 179 units |
| Distribution | Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories Gyrus Acmi, Inc., Jan 27, 2023 |