| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00187-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model numbers M3535A, M3536A, M3536J, M3536MC
Serial numbers within the following ranges:
Model M3535A: US00100100 to US00541372
Model M3536A: US00100902 to US00541375
Model M3536J: US00209838 to US00332675
Model M3536MC: US00500001 to US00500020
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD). Damage to these components can disrupt ECG and SpO2 functionality leading to an inability to perform:
- Demand mode pacing
- 12 lead ECG acquisition and analysis
- ECG monitoring via leads
- Pulse oximetry (SpO2)
The presence of this condition will be displayed on the Ready For Use (RFU) indicator as a solid Red X with periodic audio chirp. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A hardware upgrade will be provided to correct the issue. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. Philips is also advising users to immediately contact their Philips authorised service personnel if it is observed that the MRx is displaying a solid red ‘X’ in the RFU indicator and displaying the 'ECG Equip Malfunction' INOP, a failure that may disable some ECG and SpO2 functionality.
This action has been closed out on 22/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |