FDA recall Z-1385-2024

Olympus Corporation of the Americas · Class II · device

Product

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Reason for recall

A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.

Distribution

Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.

Key facts

Status
Ongoing
Initiation date
2024-01-29
Report date
2024-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2024