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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 Philips Electronics Australia Ltd
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