Class II

Medical Device Recall: Soltive Pro SuperPulsed Laser System, Model TFL-SLS

Olympus Corporation of the Americas · May 31, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

253 Units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2505-2024

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.