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The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...
ResMed's masks are safe to be used when kept at a distance of at least 6 inches away from implants or medical devices that may be adversely affected by magnetic interference, according to the ...
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.
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.
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The order states that the heads of executive departments and agencies "shall immediately take action, as appropriate and consistent with applicable law, to require compliance with CDC guidelines with respect to wearing masks, maintaining physical distance, and other public health measures" by visitors and employees of federal land and properties, and commands the Secretary of Health and Human ...
A federal agency on Friday recalled toys sold at Walmart.com containing powerful magnetic balls that could pose a hazard to children if swallowed. The Consumer Product Safety Commission said the ...
All patients are reviewed for contraindications prior to MRI scanning. Medical devices and implants are categorized as MR Safe, MR Conditional or MR Unsafe: [6] MR-Safe – The device or implant is completely non-magnetic, non-electrically conductive, and non-RF reactive, eliminating all of the primary potential threats during an MRI procedure.
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