| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01276-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillators
Model Numbers: M3535A and M3536A
Multiple Serial Numbers
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The MRx could contain incorrect internal software settings, causing the following two issues:
1. The device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended.
2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication (flashing red X with audible chirp). Instead, the RFU will show a flashing black hourglass, indicating that sufficient battery power is available for device operation. There is a potential for a delay in therapy due to insufficient battery power. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is initiating a correction that will consist of replacement of the therapy capacitor and reset of internal software settings. Prior to receiving correction, customers can continue to use the affected MRx provided that they follow workaround steps identified in the customer letter. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behaviour for no/low battery conditions.
This action has been closed out on the 26/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |