Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Recalled August 14, 2024 · FDA recall Z-2504-2024 · Olympus Corporation of the Americas

Hazard

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. · FDA Class II

Units

1,585 Units

Sold at

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

Description

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

Product

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

Manufacturer(s)

Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →