| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00980-1 |
| Product Name/Description |
Philips Respironics – Sleep & Respiratory Care Devices
BiPAP A40
DreamStation
BiPAP A30
BiPAP Auto System One 60 Series
BiPAP AVAPS C Series
BiPAP A40 Pro
BiPAP A40 EFL (ARTG)
Trilogy Evo, REMstar
SIMPLYGO and
Elegance devices
ARTG's 200289, 295664, 133794, 209934, 329407, 329408 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/10/2022 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified some sleep and respiratory care devices were supplied with a IEC52 (H02) power cord “light duty cord” instead of an IEC53 (H05) power cord “ordinary duty cord”.
The light duty cord will successfully provide power to the affected devices.
Clause 8.11.3.2 of IEC60601-1, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance”, requires medical devices to be used with an “ordinary” PVC sheathed cord (IEC53). The ordinary duty cord can withstand humidity and mechanical stresses better than light duty cord. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Hospital Use Devices:
- Upon receipt of a completed Customer Acknowledgement Form (supplied to facilities by Philips), Philips will provide replacement IEC53 power cords for affected devices.
Devices with integrated (hard wired) cords:
- Users are advised to maintain awareness of this issue. If the power cord is damaged please notify Philips on 1800 009 579.
Home use devices:
- If users would like their cord replaced, they may register their device with Philips at https://philips.to/3qGMdB5.
All new devices will be manufactured with the IEC53 power cord. |
| Contact Information |
1800 009 579 - Philips Customer Care Centre |