U.S. FDA asks Philips Respironics to notify patients about ventilator recall -Breaking
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© Reuters. FILEPHOTO: This sign can be seen at White Oak headquarters of Food and Drug Administration in Maryland on August 29, 2020. REUTERS/Andrew Kelly/File photo2/2
(Reuters) – The U.S. Food and Drug Administration (FDA), asked Philips Respironics, a Dutch manufacturer of medical equipment to inform patients about its recall of ventilators and breathing aid machines from June 2013.
FDA released a statement stating that the FDA had made it necessary to do so due to the potential harm from the products being recalled.
“Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients,” the regulator added.
According to the company, it stated in a statement that they would work with DME customers so the company can directly reach patients and other users who might not have yet been informed about the recall.
Philips Respironics recalled ventilators and breathing apparatuses last June due to a foam component that could degrade and become toxic. This might have the potential of leading to cancer.
Additionally, the regulator recommended that device owners receive monthly updates from the company. These updates should include details on replacement times and rates of recalls.
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