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.

Olympus Corporation of the Americas Medical Device Recall: Soltive Pro SuperPulsed Laser System, Model TFL-SLS | SafeCheck