| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00622-1 |
| Product Name/Description |
HeartStart MRx Monitor / Defibrillator
Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Serial Numbers: All serial numbers between US00100100 to US00567299
Manufactured between February 2004 and May 2013
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
The MRx could deliver a non-synchronised shock in the cardioversion mode if the user rotates the Therapy Knob while simultaneously pressing the 'Sync' button, then charges the MRx and presses the shock button. Delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation.
Additionally, the label affixed to the top of the MRx device is not consistent with the Instructions for Use with regard to the specific steps for the set up of delivery of a synchronised shock. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare are providing users with work around instruction as an interim measure. A software upgrade and device label revision will be supplied to users as a permanent fix. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |