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.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic Inc Model A610 DBS Clinician Programmer Application [Serial # R32J2004Z6F] [HKMD No.: 140247].
According to the MHRA, a clinician programmer tablet with Medtronic Model A610 DBS Clinician Programmer Application, Serial # R32J2004Z6F that was enrolled on a development server and not a production server, was provided to a healthcare provider (HCP). The issue was identified from a customer complaint received in May 2023. The tablet is labelled “Not for Human Use”; however, it is reported that the label is obscured by a tablet case. There have been no patient cases using the affected tablet. The manufacturer has already taken action to retrieve the tablet at the end of June 2023.
For further information, please visit https://mhra-gov.filecamp.com/s/d/A3yUkTm5Y1Yk5sDU
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Aug 2023