Recall underway

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Consumer concerns over difficulties contacting manufacturer after Philips initiates a recall of some of its CPAP and other devices

The Therapeutic Goods Administration has issued updated advice about the ongoing recall of 14 sleep and respiratory care devices supplied by Philips Electronics Australia.

In late June Philips announced that it had begun a global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

The majority of the affected devices are in the first-generation DreamStation product family, it said.

As a precautionary measure, pharmacies have been advised to quarantine and remove from sale any unsold units of the affected devices.

“Philips has identified that the foam used in the blower boxes of their continuous and non-continuous ventilators may degrade into particles, which may enter the devices’ air pathway and be ingested or inhaled by the user, and release certain chemicals as gases,” the TGA said.

“The foam may degrade more quickly if the device is cleaned using unapproved cleaning methods, such as ozone gas products.

Where possible, Philips will replace the sound abatement foam in affected devices. If this is not possible, a replacement device will be provided”.

However, on 9 July, the TGA said it was “aware that some consumers are having difficulty contacting Philips about the safety concerns with their devices. The company has advised us that additional resources are being put in place to help with the high level of calls.

It is important that customers register their devices on the Philips website. This will help us plan an effective approach to either repair or replace them, taking into account the specific needs of various patient groups”. 

It’s latest advice, issued late last week was that “some consumers have reported that they are not sure if their registration has been received. When you register you will get a registration number. If you don’t receive this number, please re-register your device. To help reduce this confusion, Philips is now sending a confirmation email with each new registration”.

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