optiejunky schreef op 17 februari 2023 07:16:
Fri, February 17, 2023 at 6:12 AM GMT+7·1 min read
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Feb 16 (Reuters) - U.S. health regulators on Thursday classified the recall of Dutch medical device maker Philips' respiratory machines as most serious, saying their use could lead to injuries or death.
The U.S. Food and Drug Administration said the silicon foam used in some of ventilator models, recalled in December, may separate from plastic backing due to adhesive failure and can reduce the air flow as well as cause debris contamination.
The company's subsidiary, Philips Respironics, had recalled about 13,811 ventilators, used to provide breathing assistance to both pediatric and adult patients, distributed between March 1, 2022 and Sept. 6, 2022.
Philips Respironics did not immediately respond to Reuters request for comment on the impact from the recall.
There were 82 complaints till Jan. 4 and no reports of death or long-term injuries associated with the use of the product, the U.S. FDA said. (Reporting by Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli)
het gaat om het loslaten v siliconen foam ( vervangend foam) van de recalled apparaten, inderdaad een recall v een recall