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ResMed was recalling some models of its continuous positive airway pressure (CPAP) masks, AirFit and AirTouch, due to possible magnetic interference with certain medical devices and implants which ...
The FDA defines a recall as a method of removing or correcting products that are in violation of laws administered by the health regulator and does not include a market withdrawal. ResMed's masks ...
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ResMed Inc. is an American medical equipment company based in San Diego, California.It primarily provides cloud-connectable medical devices for the treatment of sleep apnea (such as CPAP devices and masks), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
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related to: resmed airfit mask recall status