Class II

Medical Device Recall: SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

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

17 Units (OUS Only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1384-2024

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.

Olympus Corporation of the Americas Medical Device Recall: SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | SafeCheck