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Open, Classified

SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

FDA Recall Z-0748-2024 · Posted 2024-01-18

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2023-12-01
Product Quantity82,200 total units (5 per box)

Reason for Recall

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

Firm Action

On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at [email protected].

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183647SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)Olympus Surgical Technologies America · 2019-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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