- The FDA is alerting patients, caregivers, and health care providers that Koninklijke Philips NV PHG Respironics recalled certain bi-level positive airway pressure machines that may contain plastic contaminated with a non-compatible material.
- If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds. The plastic may also cause the machine to fail and stop working suddenly during use.
- Related: 48K New Reports On Philips Faulty Ventilator Machines.
- This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021.
- However, this new recall does apply to some of the devices recalled in June 2021.
- Philips distributed 386 affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021.
- On August 26, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter.
- Price Action: PHG shares are up 0.18% at $16.80 on the last check Monday.
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