Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Gyrus ACMI, Inc, has issued a medical device safety alert concerning its Soltive Premium SuperPulsed Laser System and Wireless Footswitch [Model number: TFL-PLS, TFL-AFSWL] [HKMD No.: 220135].
The manufacturer 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, the manufacturer 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.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Jun 2024