Recall Z-2504-2024— Olympus Corporation of the Americas

Name: FDA recall Z-2504-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-31

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-05-31. It names one FDA 510(k) clearance: K221306. Product: Soltive Premium SuperPulsed Laser System, Model TFL-PLS. Reason: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-05-31
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 System, Model TFL-PLS

Reason for recall

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

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