Two Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines had been recalled over concerns that a foam component could be dangerous.
In June 2021, certain Philips Respironics ventilators, continuous positive airway pressure and bilevel positive airway pressure machines had been recalled over concerns that a foam component could disintegrate and be inhaled by the user, possibly causing health issues including toxic and carcinogenic effects.
CERTAIN PHILIPS RESPIRONICS VENTILATORS, CONTINUOUS POSITIVE AIRWAY PRESSURE AND BILEVEL POSITIVE AIRWAY PRESSURE MACHINES The FDA said Philips should even try and provide monthly updates to device users who register their devices, including information on the replacement process. The agency said this action is necessary, saying the "company’s notification efforts to date have been inadequate."
Since the initial recall, the FDA says it's been working with the company about the effectiveness of its communications with the public. The FDA said it "has expressed concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products."
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