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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00188-1
Product Name/Description Philips HeartStart MRx Monitor/Defibrillator

Model Numbers: M3535A, M3536A, M3536J, M3536, & M3536MC

Serial Numbers:

M3535A: US00100104 - US00572207
M3536A: US00100902 - US00543688
M3536J: US00209838 - US0332675
M3536M: US00500002 - US00500009
M3536MC: US00500002 - US00500028

ARTG Number: 95661
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/02/2014
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue When used in hospital transport and pre-hospital (EMS) environments, the connection between the pads/paddles therapy cable (including pads CPR therapy cable, external paddles cable, and internal paddles cable/adapter) and the MRx therapy connection port could experience high levels of stress causing accelerated wear. Wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. This wear also could cause the MRx to inappropriately identify the pads therapy cable, external paddles, or internal paddles. Pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.
Recall Action Recall for Product Correction
Recall Action Instructions Philips will be inspecting affected units and implementing hardware corrections if required. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. However, customers are advised to ensure that ongoing therapy connection inspections are undertaken on MRx devices to detect wear. Customers are advised to remove affected devices immediately from use and contact Philips to arrange service.

This action has been closed out on 22/10/2018
Contact Information 1800 251 400 - Phillips Customer Care Centre