Recall Z-1842-2021 ยท GEX Powered Laser Surgical Instrument
Quanta System, S.p.A.
Olympus Sterile Optical Laser Fiber, single use and reusable
| Date | Apr 27, 2021 |
| Status | Terminated |
| Reason | Product sterility is potentially compromised. |
| Root cause | Process control |
| Action | The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form. |
| Quantity | 26925 units |
| Distribution | Nationwide distribution via 6 US distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180158 | Surgical Laser fibers Quanta System Spa, Feb 14, 2018 |