Philips Recalls Trilogy Evo Ventilators, Repair Kits For Potential Health Risks

The FDA has classified Koninklijke Philips NV's PHG expanded recall of certain ventilators late last year as Class 1, or the most serious type of recall.

• According to the FDA announcement, a Philips supplier had incorrectly used the polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators. 
• This issue was identified during lab testing, according to the regulator.
• Also See: Philips Registers 10% Comparable Sales Decline In Q4.
• The FDA said that the foam could break down and potentially enter the device's air pathway, leading to the user inhaling chemicals or other harmful materials.
• The Company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the U.S. in December due to potential health risks from a type of foam used in the devices.
• So far, there have been no reported injuries or deaths from the products, which were distributed in the U.S. and Korea.
• This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.
• Earlier this month, the Company raised that estimate by 1 million.
• Price Action: PHG shares are down 2.17% at $31.50 during the premarket session on the last check Thursday.