| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00735-3 |
| Product Name/Description |
Philips HeartStart MRx cardiac monitor / defibrillator, model number: M3536A with R.03.03 software and 12 Lead option (manual defibrillator)
Model number: M3536A with R.03.03 software and 12 Lead option (or with the capability to install 12 lead option)
Manufactured between April 17 2012 and May 8 2012
Multiple serial numbers
ARTG number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
Due to a corrupt data card some HeartStart MRx defibrillator/monitors manufactured within these time periods may have incomplete 12-Lead program files, and if so will present the following behaviour:
- The device cannot analyse a 12-Lead ECG report. Due to this a user cannot view, print or transmit a 12-Lead ECG.
- A message 'Cannot Analyse ECG' is displayed on the MRx when an attempt to acquire a 12-Lead report is made.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
User may continue to use an affected device, however the 12 lead report will not be generated, Philips Healthcare recommends have a back up device available. Philips Healthcare will be providing a software update to permanently correct the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |