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, Medtronic, has issued a medical device safety alert concerning Valleylab FT10 FT Series Energy Platform [Model Number: VLFT10GEN; All Serial Numbers running software versions 4.0.1, 4.0.2 and 4.0.3] [HKMD No.: 170041].
The manufacturer has noted that upon insertion of a new (unused) LigaSure device, the Valleylab FT10 Energy Platform running software versions 4.0.1, 4.0.2 and 4.0.3 may erroneously indicate that the LigaSure device was used previously. When this occurs, the energy platform will display error “E420 Usage Limit” or error “E416 Unknown Instrument,” and the LigaSure device would not be allowed to be used. Through 7 Nov 2023, there have been 113 complaints for this issue. Upgrading the Valleylab FT10 Energy Platform to the newly released software version 4.0.4 will eliminate this issue.
Affected users should follow the action listed on the customer letter issued by the manufacturer.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Nov 2023