FDA-Device2024-08-14Class II
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Olympus Corporation of the Americas
Hazard
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Affected count
1,838 Units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2506-2024Don't want to check this manually?
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