| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-00538-1 |
| Product Name/Description |
Philips HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED
ARTG 92346
(Philips Electronics Australia Ltd Defibrillator - Non-rechargeable semi-automatic external defibrillator) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/02/2021 |
| Responsible Entity |
|
| Reason/Issue |
Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED may be among fewer than 300 units globally that may have been omitted from one or more previous recalls due to a serial number issue. The potential recalls that the affected units may have missed include the following:
FR2+ Board Contamination (RES 36662)
FR2+ Product Correction SRAM memory chip failure (RES 53383)
FR2+ U34 Product Recall (RES 56816)
FR2+ U8 Recall (RES 55682)
FRx, HS1 Field Action for PCA Failed Supplier Testing Procedure (RES 84850)
HS1 Button Recall (RES 47833)
HS1 Contact Pin Contamination (RES 67612)
HS1 Quick Reference Card Corrective Action (RES N/A)
HS1/FRx Capacitor Recall (RES 53816)
HS1/FRx Relay Recall (55579)
HS1/FRx Reminder to Call Service upon a Triple Chirp Self-Test (R92) (RES 79343, 63030) |
| Recall Action |
Recall |
| Recall Action Instructions |
Philips will exchange affected devices with a replacement Philips AED free of charge. A Philips representative will reach out to customers to help them identify any affected AEDs.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |