| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-01373-1 |
| Product Name/Description |
Philips Respironics CPAP and Bi-Level PAP Devices
E30 (Emergency Use Authorization)
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
SystemOne (Q-Series)
DreamStation
DreamStation Go
All devices manufactured before 26 April 2021
ARTG's: 133792, 209934, 235674, 257012, 257013, 295664, 285420, 327227, 335508 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/07/2021 |
| Responsible Entity |
|
| Reason/Issue |
Two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators:
1) PE-PUR foam may degrade into particles which may enter the devices’ air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and
2) the PE-PUR foam may off-gas certain chemicals. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the device’s useful life.
The potential risks associated with these issues include: headache / dizziness, irritation (eyes, nose, respiratory tract, skin), inflammatory response, asthma, adverse effects to other organs (e.g. kidneys and liver), hypersensitivity, nausea / vomiting, toxic and carcinogenic effects.
To date, there is no definitive evidence of long-term harm and there have been no reported deaths as a result of these issues. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Patients:
Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Together with a physician, determine if the benefit of continuing therapy with the device outweighs the risks identified and discuss alternative long term therapy options.
Register the device on the recall website: www.philips.com/src-update
Physicians:
Please review the information outlined above. For patients who request review of their therapy and/or patients on affected devices owned by physicians and/or their organisation undertake a patient-specific risk assessment to determine whether the benefits of continuing therapy outweighs the risks identified.
Retailers/Distributors:
Cease all supply and distribution of impacted devices.
Where possible, Philips will replace the affected foam component in impacted devices. |
| Contact Information |
1800 009 579 - Philips Recall Support Hotline |