Recall Z-2504-2024 ยท GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
| Date | Aug 5, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. |
| Root cause | Device Design |
| Action | On 06/28/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of these products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and t |
| Quantity | 1,585 Units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore. |
| 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 |