| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00339-1 |
| Product Name/Description |
Philips HeartStart Home and OnSite (HS1) Automated External Defibrillators
Model numbers: M5066A and M5068A
Serial number range : A13G-00047 to A136-006576
ARTG number: 92346 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Phillips has determined in a limited number of HeartStart Home and OnSite (HS1) AEDs, one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED resulting in the device being unable to deliver therapy. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to identify if they have an affected AED and contact Philips immediately. Philips is advising that if no alternative is available that AEDs should be kept in service until replacement unit can be supplied. This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |