Z-1715-2025Class II

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System...

Name: Z-1715-2025 Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System...
Creator: Olympus Corporation of the Americas
Published: 2025-04-04
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-04-04 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description... on 2025-04-04. FDA classified it as Class II and gives the reason as "Preset treatment parameters are not consistently being used in accordance with the IFU". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1715-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-04
Posted: 2025-05-01
Recalling firm: OLYMPUS Corporation of the Americas
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
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Preset treatment parameters are not consistently being used in accordance with the IFU.
Root cause tag: labeling and UDI
FDA 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 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
Quantity in commerce: 189
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1715-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1715-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-05-01

Product code GEX

K242191Class IISOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America / cleared 2024-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)