PlainRecalls
FDA Devices Moderate Class II Ongoing

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Reported: April 3, 2024 Initiated: January 29, 2024 #Z-1384-2024

Product Description

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

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.

Details

Units Affected
17 Units (OUS Only)
Distribution
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
SOLTIVE Pro SuperPulsed Laser (TFL-SLS ). Recalled by Olympus Corporation of the Americas. Units affected: 17 Units (OUS Only).
Why was this product recalled?
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1384-2024.