Recall Z-1385-2024— Olympus Corporation of the Americas

Name: FDA recall Z-1385-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-29

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-01-29. It names one FDA 510(k) clearance: K221306. Product: SOLTIVE Premium SuperPulsed Laser (TFL-PLS ). Reason: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-01-29
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc.·cleared 2023-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Reason for recall

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

Data sourced from openFDA. This site is unofficial and independent of the FDA.