Class II
Medical Device Recall: SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Olympus Corporation of the Americas · January 29, 2024
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.
States Affected
IN
Quantity Affected
203 Units (OUS Only)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1385-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.