| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00149-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillators
Units Affected:
Model - Serial numbers
M3535A: US00100100 to US00578696
M3536A: US00100902 to US00576650
M3536J: US00209838 to US00332675
M3536M: US00500002 to US00553553
M3536MC: US00500001 to US00500087
M3536M2: US00554176, US00554177, US00554178
M3536M5: US00500001 to US00562935
M3536M6: US00554358 to US00576619
ARTG number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
The MRx could reboot once in any operating mode if the following sequence occurs:
1. In Service Mode, the Status Log is cleared
2. Prior to exiting Service Mode, the MRx generates an entry in the Status Log.
3. Service Mode is exited.
The MRx will restart within 8 seconds. If a reboot occurs during clinical use, current device settings and patient record are retained. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software upgrade will be provided to correct the issue. Philips is advising end users that the MRx can continue to be used prior to receiving the software update. End users are advised that if the MRx reboots during clinical use, continue to treat the patient according to your organisation’s protocol, reinitiating therapy if necessary.
This action has been closed out on the 26/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |