Z-0135-2025Class II

Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation...

Name: Z-0135-2025 Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation...
Creator: Olympus Corporation of the Americas
Published: 2024-08-13
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-08-13 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue... on 2024-08-13. FDA classified it as Class II and gives the reason as "The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0135-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-13
Posted: 2024-10-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
FDA root cause: Under Investigation by firm
Action: Olympus issued Urgent Medical Device Correction Letter on 9/12/24 to Operating Room Director, Risk Management. Letter states reason foe recall, health risk and action to take: 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. If you have further distributed this product, identify your customers, and forward them this notification. 5. 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: "0452 c. Complete the form as instructed. If you require additional information, please do not hesitate to contact me at [email protected] or by phone at (647) 999-3203
Quantity in commerce: 159 units
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Product codes and lots: UDI 00821925044135 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0135-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18
Z-0135-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-18

Product code GEX

K221306Class IISOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc. / cleared 2023-01-27

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)