Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Nu

FDA device recall Z-1695-2026 · posted 2026-03-30 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Action taken

On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the replacement of the 24V module in this corrective action will follow the standard SOLTIVE Laser repair process and your service contract, if applicable. 4. If you have further distributed the affected products, please forward this notice to other users who may be impacted.

Root cause

Process control

Status

Open, Classified

Product code

GEX

Quantity affected

32 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

Date initiated

2026-02-27

Date posted

2026-03-30

Location

Center Valley, PA

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