Last Updated on January 14, 2024 by The Health Master
Bengaluru: The U.S. Food and Drug Administration (USFDA) classified the recall of Dutch medical device maker Philips’ respiratory machines as most serious, saying their use could lead to injuries or death.
The silicon foam used in some modified ventilator models may separate from plastic backing due to adhesive failure, the U.S. health regulator warned. This can reduce air flow and result in debris contamination.
The company’s ventilators provide breathing assistance to both pediatric and adult patients.
The action was taken in response to Philips’ decision to recall millions of breathing apparatuses and ventilators in June 2021 over concerns that a foam component could deteriorate and turn toxic, possibly leading to cancer.
In December, Philips Respironics, a subsidiary of this company, also announced the recall of 13,811 ventilators that were sold between March 1 and September 6, 2022.
There were 82 complaints until Jan. 4 and no reports of death or long-term injuries associated with the use of the product, the USFDA said.
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