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SOLTIVE recallZ-1715-2025 · Olympus Corporation of the Americas · initiated Apr 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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

Recall details

Recall number
Z-1715-2025
Status
Open, Classified
Initiated by the company
Apr 4, 2025
Posted by the FDA
May 1, 2025
Recalling firm
Olympus Corporation of the Americas
Quantity
189
Product code
GEX
FDA submissions
K242191
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

12 devices cleared under K242191 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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