Recall Z-1715-2025 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No
| Date | May 1, 2025 (initiated Apr 4, 2025) |
| Status | Open, Classified |
| Reason | Preset treatment parameters are not consistently being used in accordance with the IFU. |
| Root cause | Unknown/Undetermined by firm |
| Action | On April 4, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Olympus will contact you to schedule time for an Olympus Field Representative to visit your facility and install the software update. Additionally, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Please check all areas of your facility to determine if you have the devices specified above. 3. Ensure all personnel are completely knowledgeable and t |
| Quantity | 189 |
| Distribution | Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Acc Olympus Surgical Technologies America, Aug 23, 2024 |