| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00517-1 |
| Product Name/Description |
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
ARTG 327303
(Welch Allyn Australia Pty Limited - Thermometer, infrared, ear) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers may continue to use the PRO 6000 ear thermometers according to the current IFU.
Customers are to download the correct IFU and discard all versions of the outdated IFU.
Update: 7/8/2024
- Instruct all users to follow cleaning instructions in IFU Maintenance and Service section for proper cleaning - a Cleaning Guide has been sent to customers.
- Do not use the device if the ring around the measurement button shows a green blinking or flashing light instead of a ready state (solid green light). Contact Baxter Technical Support to report this.
- Do not use the device if the device requires multiple power-ups prior to going to ready state (solid green light). Contact Baxter Technical Support to report this.
- If the probe tip overheats, do not use the device and contact Baxter Technical Support to report this. |
| Contact Information |
1800 445 576 - Baxter Healthcare Customer Service |