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Philips flags new problems with previously-replaced ventilators
The FDA said the company had notified it that the sound abatement foam could come loose in some refurbished models, "lowering the inspiratory pressure".
Amsterdam: Philips, which has been struggling with a major recall of ventilators, on Monday flagged further problems with some machines it has previously replaced, according to an FDA statement.
A Philips spokesperson said that only Trilogy 100/200 venilator models were potentially affected.
The FDA said the company had notified it that the sound abatement foam could come loose in some refurbished models, "lowering the inspiratory pressure".
In addition, trace amounts of particulate matter were found in the air pathways of some reworked ventilators.
Read also: Philips expanded ventilator recall classified as most serious by USFDA
Philips has replaced more than 4 million ventilators and sleep apnoea machines over the past 18 months due to worries that the foam used in the machines could become toxic.
The spokesperson said Trilogy 100/200 ventilators represent around 3% of the recall, and no sleep apnoea machines were affected.
Philips shares declined 1.3% to 13.55 euros in Amsterdam.
Read also: Philips recalls some masks used with respiratory devices over safety issues
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751