Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Numbe

FDA device recall Z-1921-2025 · posted 2025-06-06 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Action taken

On May 6, 2025 URGENT: MEDICAL DECIVE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this letter, including Appendix 1 detailing the relevant Instructions for Use sections. 2. Ensure all surgeons and personnel are completely knowledgeable and thoroughly trained on the content of this letter, the instructions provided for detecting fiber damage, Appendix 1, and the SOLTIVE Laser System and Fibers Instructions for Use. Include a copy of this letter with the Instructions for Use. You may continue to use the device as per this letter and the Instructions for Use. 3. 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: "0470 c. Complete the form as instructed. 4. If you have further distributed this product, identify and forward them this letter. Olympus requests you to report any complaints, including fiber damage/breaks, smoke, sparks, flare, burning of a device or equipment, unsteady flames, steady flames and burns to a clinician or supporting staff occurring while using the SOLTIVE Laser Systems and SOLTIVE Laser Fibers. Olympus requests that you send the involved fiber(s) to Olympus for complaint investigation purposes. Please report complaints 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 also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEX

Quantity affected

1549 units (1025 US, 524 OUS)

Distribution

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

Date initiated

2025-05-06

Date posted

2025-06-06

Location

Center Valley, PA

Related 510(k) clearances