| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00112-1 |
| Product Name/Description |
Philips HeartStart XL+ Defibrillator/Monitor
Model number 861290
Multiple Serial Numbers affected
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
4/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Philips HeartStart XL+ Defibrillator/Monitor battery may take slightly longer to charge to 100% at 35 deg C than specified in the Instructions for Use (IFU). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing users with an addendum to the Instructions for Use (IFU) specifying the battery charge time and temperature specifications. The addendum specifies the proper battery charge time with the device turned off and PC power connectors i.e., with temperature at 25 deg C (77 deg F), it will take less than 3 hours to charge at100% capacity and less than 2 hours to charge at 80% capacity. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |