[Recalled] Soltive Laser System — Device compatibility - Performance | Health Canada 2024-07-12

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: 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

This recall concerns General hospital and personal use products distributed in Canada and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.