| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01438-1 |
| Product Name/Description |
BiPAP A 40 Ventilatory Support System
Product code: 1111171
Detachable Battery Module, USA/INTL
Product code: 1096770
ARTG Number: 200289 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips Respironics has identified an issue where a non-conforming part (side panel) was utilised on the BiPAP A40 that affects the mechanical connection between the BiPAP A40 and the Detachable Battery Module (part number 109677). The issue results in the inability to connect the BiPAP A40 device to the Detachable Battery Module during setup before putting the ventilator into operation on a user; therefore, there is no safety risk to the patient. The impacted BiPAP A40 units continue to work properly in configurations without the Detachable Battery Module.
A non-conforming part was utilised on the BiPAP A40 that affects the mechanical connection between the BiPAP A40 and the Detachable Battery Module |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Complete the inspection of the devices for the potentially faulty side panel per the inspection instructions provided with the letter.
2. Complete and return Business Reply Form (BRF) and list the total quantity inspected, the quantity of correct devices, and the quantity of incorrect devices.
3. Contact your local Customer Service who will provide direction on how to return your device(s) for any confirmed faulty side panel replacement.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1300 766 488 - Philips Respironics Customer Service |