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 issued a medical device safety alert concerning TactiSys Quartz Equipment [Model: PN-004 400; Part numbers: 100110641, 600075377, 600075378] [HKMD No.: 150121].
The manufacturer has identified that the Instructions for Use (IFU) insert was not included in the packaging for TactiSys Quartz equipment [Model: PN-004 400] part numbers 100110641, 600075377 and 600075375.
According to the manufacturer, the affected units were packaged without the IFU insert. Based on the 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 5 Dec 2023