| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00948-1 |
| Product Name/Description |
HeartStart Intrepid Monitor/Defibrillator
Product code: 867172
ARTG 281589
(Philips Electronics Australia Ltd - Physiologic-monitoring defibrillation system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
The current HeartStart Intrepid Service Manual does not detail IEC Class I electrical safety test verification methods. The lack of this testing does not introduce a failure, but it may prevent a failure from being detected. This could occur when an IEC Class I device is tested as a Class II device after a servicing event.
The issue was identified as the result of a service provider’s inquiry. There have been no reports of patient harm. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that:
- The HeartStart Intrepid Monitor/Defibrillator may continue to be used if: the Class I device that has been opened and serviced is tested using the updated Service Manual which will be supplied to affected customers. A hard copy of the Service Manual Addendum will be supplied to customers along with the customer service letter. For customers using a CD version of the manual, they are to follow the hardcopy version provided.
Philips will contact customers to arrange complimentary retesting to Class I as necessary. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |