Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators collection
This recall action was first published on our website on 18 June 2021 and updates from June 2021 to July 2022 are contained within the first recall. Further updates are published to this collection.
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About this recall action
The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators. Risks are 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.
We continue to work with Phillips to ensure that information is made available through on the TGA website and from Phillips directly to customers. For questions about this issue:
- contact Philips Electronics Australia Ltd support hotline on 1800 009 579
- visit www.philips.com/src-update.
Collection content
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Recall actionsThe affected bi-level positive airway pressure (BiPAP) devices may stop providing therapy on an intermittent or permanent basis and the ‘Ventilator Inoperative’ alarm will sound.
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Media releasesIf you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.
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Safety alertsPhilips Respironics (the manufacturer) detected two problems with corrected Trilogy 100 ventilators
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Safety alertsSafety alert relating to CPAP and BiPAP face and nasal masks that contain magnets which may cause active implantable devices to malfunction
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Recall actionsUpdate on Trilogy 100 Ventilators
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Media releasesThe TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are affected by the recall action.
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Recall actionsPhilips Respironics patient interface devices (face and nasal masks) with magnetic clips - New warnings
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Recall actionsUpdate on BiPAP settings issues and recall progress
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Recall actionsThis page contains the original recall in June 2021 and progress updates to 2024.