| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00365-1 |
| Product Name/Description |
Philips HeartStart XL Defibrillator/Monitor
Model number M4735A
ARTG 95661
(Philips Electronics Australia Ltd Defibrillator, manual) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/05/2020 |
| Responsible Entity |
|
| Reason/Issue |
The Philips HeartStart XL Defibrillator/Monitor rotary therapy selector switch (Energy Select Knob) may fail, resulting in unexpected device behaviour. These behaviours include:
1) The device may not turn on;
2) The device may not perform the selected function; and/or
3) The device may deliver a shock with an energy level different from the setting selected by the user.
There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch (Energy Select Knob). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising customers that identify a device that exhibit any of the behaviours described above or fails shift or operational checks, immediately remove it from service.
Philips intends to take no further action beyond notifying customers to retire the XL as soon as practically possible: the XL is beyond its support life and is no longer serviceable.
Customers are advised to continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired.
This action has been closed out on 26/03/2024 |
| Contact Information |
1800 251 400 - Philips Customer Service |