It’s Class I For June Recall Of Philips Breathing And Ventilator Devices
The US FDA on 22 July designated a recent recall by Royal Philips of certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices as high-risk class I.
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The US FDA has labelled as class I an August recall of Philips Respironics BiPAP machines due to the potential of hazardous chemicals being inhaled by the user or shutting down the machines.
Specific Trilogy Evo ventilators and their repair kits have been recalled because a Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) foam, a nonconforming material, in the manufacture of their muffler assembly. The US FDA gave the recall a high-risk designation on 26 January.
Royal Philips says a first round of testing on its first generation DreamStation has found that the level of volatile organic compounds (VOCs) put off by the recalled device “is not typically anticipated to result in long-term health consequences for patients.”