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Important Notice: Philips Issues Medical Device Recall

Jun 24, 2021

What happened?

Philips Respironics recently announced a voluntary recall of certain Bi-Level PAP, CPAP, and mechanical ventilator devices, due to problems with the foam sound abatement system in these devices. This foam may degrade into particles, which device users may then inhale or ingest, and off-gas certain chemicals. Health risks related to ingestion or inhalation of the particles and off-gassing include headache, irritation, hypersensitivity, nausea, vomiting, and possible toxic or carcinogenic effects. To learn more, review Philips Respironics Medical Device Recall Notification Information for Physicians and other Medical Care Providers.

Why is this important?

While the primary target of a medical device negligent design or manufacture lawsuit is typically the manufacturer, plaintiffs routinely include claims against physicians in order to defeat federal jurisdiction.

In some states, continuing to distribute a product after a company issues a voluntary recall can give rise to liability for failure to warn. A failure to warn claim asserted against a physician arises under products liability law and not under state medical liability law. Therefore, many medical professional liability protections built into medical liability law, such as medical review panel screening, affidavits of merit, damages limitations, separate statutes of limitations, and expert witness testimony, may be inapplicable.

What should you do?

If you are presently selling, distributing, prescribing, or recommending these products, stop immediately. Develop a plan to identify any patients who are users of the products subject to this recall. Notify these patients in writing about the recall, inform them of the risks of continued use, and discuss any modifications to the patient’s treatment plan that may be necessary. Save a copy of this notification in the patient’s medical record.

Healthcare organizations should have a process in place that outlines the steps for responding to a device recall. This may include the completion of an incident report submitted to risk management and follow-up to ensure an appropriate recall response, including the removal of recalled devices from storage and stock.

Contact us

To report a patient who may have been adversely affected by these products, we ask that insureds use the secure Report a Claim link or call 800.416.0791.

Additionally, our Risk Management Specialists are available to discuss patient safety and medical liability issues. Simply email risksolutions@norcal-group.com or call 855.882.3412.

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