- The FDA said Koninklijke Philips NV (NYSE:PHG) recalled certain masks used with some of its respiratory machines due to the potential risk of serious injury.
- The company said the masks have magnetic headgear clips or straps that can interfere with certain implanted metallic medical devices and objects in the body, causing potential injuries or death.
- Last week, FDA alerted patients, caregivers, and health care providers that Philips’ Respironics recalled certain bi-level positive airway pressure machines that may contain plastic contaminated with a non-compatible material.
- Related: Philips’ Subsidiary To Pay Over $24M For Alleged False Claims For Respiratory-Related Equipment.
- Philips’ unit, Respironics, has distributed more than 17 million masks containing magnetic clips.
- According to the FDA, the unit has received 14 reports of injuries following the masks as of Aug. 30, including pacemaker interference and pacemaker failure leading to replacement.
- The health regulator monitored the situation and worked with Philips on the recalled devices.
- Price Action: PHG shares closed 5% higher at $17 on Tuesday.
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