Olympus Corporation of the Americas: Device Recall

Recall #Z-2506-2024 · 05/31/2024

Class II: Risk

Recall Details

Recall Number
Z-2506-2024
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
05/31/2024
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,838 Units

Reason for Recall

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

Product Description

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

Distribution Pattern

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

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.