| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00290-1 |
| Product Name/Description |
Rad-G Device and Rad-G Device with temp
Part numbers: 27977 and 27978
Multiple serial numbers
ARTG 138873
(Masimo Australia Pty Ltd - Oximeter, pulse) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Rad-G devices are powering off and on without pressing the power button. Masimo’s investigation identified a problem that can result in an unintentional change in the power state.
Masimo has received a total of 529 complaints related to this issue. Masimo has received two reports of patient deaths while being monitored with Rad-G devices. If the device powers off unexpectedly, it could result in a loss of monitoring, which could potentially result in a delay in patient care. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Inspect and quarantine any affected devices to prevent further use.
- Contact Masimo Technical Services to request return of the affected product for repair or replacement (more details provided in the customer letter supplied by the Sponsor). |
| Contact Information |
02 9452 4334 - anz@masimo.com - Masimo Australia |