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 States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Philips North America ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 [REF number 706100, 709030, 709031; Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067, 10001076, 10001071, 10001072, 10001086, 10001087, 10001114] [HKMD No.: 210062].
According to the FDA, the manufacturer has identified a compliance issue where the affected products are missing a certification label required by the FDA
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92333
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 May 2023