| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00993-1 |
| Product Name/Description |
HeartStart XL Defibrillator Battery / Monitor, model M3516A (manual defibrillator).
Units Affected: HeartStart XL battery M3516A labelled with 'Made in Taiwan' and date of manufacture 'R-2011-12'
ARTG Number : 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
If the XL Defibrillator/Monitor (M4735A) is used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are being advised to identify whether they are using the defibrillators with a defective battery and to operate the affected HeartStart XL Defibrillator/Monitor using AC power supply only. Philips will be providing affected customers with a replacement battery(s) as soon as a new production of batteries are available. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |