Medical device manufacturer Philips announced the company will expand on a previous recall in an ongoing effort to remove equipment that could have a contaminant in one of the plastic components.
Philips said the recall of respiratory machines with possible non-compatible material in one of the plastic components had reached 1,700 devices globally, Reuters reported.
No reports of injuries or harm to patients had been reported, according to Philips Respironics, which is a subsidiary of Philips.
Out of the 1,700 devices included in the voluntary recall, 386 of them were reported in the United States, but none of them were reported in the Netherlands, where the Dutch company is based.
According to the U.S. Food and Drug Administration (FDA), certain bi-level positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines are affected. Machines with affected components could have plastic in the device motor that could release certain volatile organic compounds (VOCs).
Machines could also fail and stop working suddenly, the FDA said in a statement.
386 machines were delivered to the U.S. by Philips between Aug. 6, 2020 and Sept. 1, 2021. Machines with serial numbers contained in the "Urgent Medical Device Recall" letter are affected, including:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Download and read the full letterhere.
The potential risk of inhaling VOCs includes headache and dizziness. One could also experience irritation of the eyes, nose, airway, and skin. An allergic reaction could also be experienced as well as nausea or vomiting and there could be cancer-causing effects, the FDA said.
