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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Kaz USA, Inc., A Helen of Troy Company Braun Thermoscan PRO 6000 Ear Thermometers with Small and Large Cradle [Product codes: 06000-200 and 06000-300; Device Identifier: 00732094309003 and 00732094309027; Serial number: All][HKMD number: 180167].
According to the TGA, the Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). The affected product was shipped to customers between 15/09/2022 and 22/02/2024. The current, correct IFU includes an additional warning regarding proper cleaning, and the risks associated with the speculum tip potentially overheating due to fluid ingress.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00517-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Jun 2024