—#213177

Product

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

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K242191
Affected lot / code info: SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-PLS - 00821925044111 All units included Powered Laser Surgical Instrument - Laser module component information Name: TFL Premium Laser Unit, TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586; TFL-CSLU - 00821925044593

Why it was recalled

Preset treatment parameters are not consistently being used in accordance with the IFU.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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 thoroughly trained on the content of this notification and the SOLTIVE Laser System Instructions for Use. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0469 c. Complete the form as instructed. 5. Olympus will contact you to schedule time for an Olympus Field Representative to visit your facility and install the software update. Olympus s record of the completed software update on your SOLTIVE system(s) will serve as the acknowledgment of this field corrective action for your facility. 6. Following the installation of the software update on your SOLTIVE system(s), ensure all personnel are thoroughly trained on the attached IFU Addendum corresponding with this update. The updated version of the full IFU can be located electronically at OlympusConnect.com. If you would like to receive a physical copy of the updated IFU, please submit a request in the comments of our recall portal when submitting your acknowledgement. 7. If you have further distributed this product, identify and forward them this notification. Olympus requests that you report any complaints related to the SOLTIVE Laser System or any associated injuries to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may al

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.

Timeline

Recall initiated: 2025-04-04
Posted by FDA: 2025-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.