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Health Canada Medical devices

Soltive Laser System

Issued July 12, 2024
Issue
Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser. Recall start date: June 28, 2024
Hazard description
Device compatibility - Performance
Product
Product name
Soltive Laser System
Reference
ID
RA-75813