Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-00736-3 |
Product Name/Description |
Philips HeartStart MRx cardiac monitor / defibrillators, models:M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5 and M3536M6 (manual defibrillator)
All units manufactured prior to June 2012
(Model / manufacture date is printed on the primary label on the back of battery bay B)
ARTG Number: 95661 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
19/07/2012 |
Responsible Entity |
|
Reason/Issue |
When HeartStart MRx Defibrillator Monitors are used in external transport and EMS environments the mechanical/electrical connection between the pads/paddles therapy cable (including pads CPR therapy cable and external paddles cable) and the MRx therapy connection port may experience higher than expected levels of stress causing accelerated wear. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Philips is revising the Instructions for Use (IFU) to include additional requirements and instructions for ongoing inspections of these devices, informing users that the lifespan of this device is 3 years and is providing support for users needing to replace cables. |
Contact Information |
1800 251 400 - Philips Customer Care Centre |