| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00477-1 |
| Product Name/Description |
Philips HeartStart XL+ Defibrillator/Monitor
Model Number: 861290.
Units upgraded to B.00.01 software, or manufactured by Philips between December, 2013 and February, 2014
Multiple serial numbers affected
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
A software communication failure on the HeartStart XL+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. The communication error can trigger a false failure condition - error code 1:34 "Equipment Disable: Therapy". If the user is locked out of clinical mode, a delay in therapy may occur, which could pose a risk for patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing a software update to correct the issue. End users are advised while awaiting the software upgrade for the affected device users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: “Equipment Disabled: Therapy”. This is an indicator that the device self-test has detected the problem and is not ready for use. In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure. This action has been closed-out on 01/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |