| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00209-1 |
| Product Name/Description |
Philips HeartStart XL, Defibrillator/Monitor
Model Number: M4735A
Units Affected: Units manufactured by Philips between May, 2013 and November, 2013
Serial numbers within the range: US00101665 to US00608704 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
An internal component on the HeartStart XL power board may malfunction potentially affecting the ability to deliver therapy. Specifically, the XL may be unable to charge and deliver a shock. In addition, when used for external pacing, the malfunction may result in a loss of capture. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will be installing replacement power boards to correct the problem. A Philips representative will be in contact with customers to make arrangements for the correction. While awaiting the replacement power board for the device, users may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |