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FDA asks Philips to conduct more testing on foam in recalled ventilators

by John R. Fischer, Senior Reporter | November 17, 2021

And while the FDA is not yet sure if the silicone-based foam that Philips is using instead is safe either, it does not recommend that patients stop using the company’s products, due to the risks versus the benefits of them.

"Until we have concluded these discussions, we are not able to publicly provide further details,” said van Houten.

Two of the company’s other devices recalled in June were its V60 and V60 Plus ventilators, which were found to pose a risk of reducing oxygen flow to patients in certain situations. The issue was part of its software version 3.00 and 3.10 upgrades and specifically had to do with a safety mechanism of the High Flow Therapy option that limits both pressure and flow rate when the system hits its maximum limit. This leads to a partial obstruction in the breathing circuit, according to Philips.

The FDA in August labeled the V60 and V60 Plus recall as Class one, the most serious type of recall. It said that the use of such devices could result in serious injury or death and reported 61 incidents and 25 injuries that could be traced back to them.

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