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, St. Jude Medical, has posted a medical device safety alert concerning TactiSys Quartz PN-004 400 [Part Numbers 100110641, 600075377, 600075378] [HKMD No.: 150121].
According to the manufacturer, the units referenced above were packaged without the IFU insert. Based on the manufacturer's risk analysis, it is unlikely that an adverse health consequence will occur due to exclusion of the IFU insert. The user could potentially experience a procedure delay if information necessary to connect, operate, or troubleshoot the TactiSys Quartz hardware is needed and unavailable during a procedure.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 Sep 2023