| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01268-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
All Models that received an M4760A Handle and Cap Plate Upgrade shipped before 2010
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The handle can separate from the MRx housing due to breakage of mounts on the rear case. Separation of the handle from the MRx housing can cause the MRx to fall, potentially injuring the patient or user. In addition, a delay of therapy could occur if the device is damaged by the impact |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A hardware upgrade will be provided free of charge for all units affected by this issue. Customers are advised to continue to use their MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat the patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit.
This action has been closed out on 21/01/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |