| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00231-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model numbers: M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464, 861483, and 861491
Units Affected: Serial numbers within the range US00100204 to US00570921
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
An internal component on the HeartStart MRx therapy board may malfunction potentially affecting the ability to deliver therapy. Specifically, the MRx may be unable to charge and deliver a shock. In addition, when used for external pacing, the malfunction may result in a loss of capture during pacing.
The MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is initiating a correction to the affected devices. A hardware upgrade will be provided to customers with affected devices.
Philips is advising users that they can continue to use their MRx prior to receiving the hardware upgrade, provided that if it is observed that the MRx is displaying a Red X in the Ready For Use (RFU) indicator during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this occurs, remove from use and call for a service. Identify a readily available back up defibrillator to use in the event the affected MRx fails to deliver therapy.
This action has been closed out on 22/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |