FDA recall Z-2504-2024

Olympus Corporation of the Americas · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-05-31
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2504-2024