(CercleFinance.com) – The US FDA announced last Friday that Philips informed it of two new potential issues with its respiratory assistance devices that were recalled in June 2021.
The US health authority says the Dutch group told it it had identified a possible risk of separation from the new silicone foam used to replace the controversial polyester-based polyurethane foam that was behind the recall.
The FDA explains that this compound can indeed separate from the plastic support of the device and have an impact on its performance by blocking the entry of air and thus decreasing the inspiratory pressure.
Another difficulty, traces of particles were found in the air circuit of some repaired and replaced fans, which turned out to be in some cases residues of soundproofing foam made of polyester-based polyurethane (PE-PUR).
In 2021, Philips had to issue a recall notification on some of its respiratory assistance devices in order to limit the potential health risks associated with this soundproofing foam.
Following this announcement, Philips shares fell 2.5% on the Amsterdam Stock Exchange on Monday, posting one of the biggest drops in the AEX index at the start of the afternoon.
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