Controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2022
FDA recommends prioritizing vulnerable patients for Philips Respironics recall replacements
Corrective action
The FDA recommended that Philips Respironics prioritize replacement devices for patients most vulnerable to poor health outcomes from continuing to use or stopping use of recalled products. The FDA said its recommendation followed concerns that a first-come, first-served approach might not address some patients’ health risks.
Source excerpt
On March 14, 2022, the US Food and Drug Administration (FDA) updated its frequently asked questions about the Philips Respironics CPAP, BiPAP, and ventilator recall to include information about Philips Respironics’ prioritization strategy for replacement devices.
The FDA has recommended Philips Respironics implement a prioritization approach that ensures patients who are most vulnerable to poor healthcare outcomes with continued use or ceasing use of the recalled products receive replacement devices as quickly as possible.
The administration notes that a first-come, first-served replacement strategy may not address health risks for some patients.
2021
Foam degradation and respiratory-device recall
Philips Respironics recalled certain CPAP, BiPAP, and ventilator devices after identifying a potential hazard involving degradation of polyester-based polyurethane foam. Regulators, patients, journalists, and litigants subsequently scrutinized the company’s complaint reporting, risk assessment, communications, and remediation. Claims concerning injuries and illnesses have been contested and adjudicated through multiple legal processes; the recall itself and the related regulatory findings are established.