FDA Labels Philips’ Expanded Ventilator Recall ‘Most Serious’

Philips

The U.S. Food and Drug Administration (FDA) has labeled Philips’ expanded ventilator recall as a Class 1 action, which is reserved for medical devices that pose the risk of serious injury or death.

According to a Reuters news report, the Dutch medical equipment company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the United States in December because of potential health risks from a type of foam used in the devices.

Ventilator Recall: Risk of Serious Injury or Death

So far no injuries or deaths have been reported from the products, which were distributed in the United States and Korea, the FDA said. Philips officials issued a statement to Reuters saying they have already reached the majority of affected customers and would correct the issue through a repair (replacement of the foam) in the coming months.

This is the most recent ventilator 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. The company said a supplier had incorrectly used a type of polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators – an issue that was identified during lab testing, FDA officials said.

The supplier used polyester-based polyurethane foam instead of a polyether-based one, which is specified for these products in order to meet all applicable standards. The polyester foam could potentially break down and potentially enter the device’s air pathway, leading to the user inhaling chemicals or other harmful materials, the FDA said.

The agency noted incorrect use of the foam in Trilogy Evo ventilators manufactured from April 15 to May 24, 2021. Philips has said it plans to provide replacement devices and take the affected machines back from customers through the ventilator recall.

Product Liability Issues

Anyone who has been affected by a defective medical device can file a product liability claim against the manufacturer of the defective product. In cases where a person has died, his or her family can file a wrongful death claim against the product manufacturer.

Victims or families of deceased victims would be well advised to contact an experienced product liability lawyer who will ensure that the negligent manufacturers are held liable. The best product defect law firms will always offer a free consultation and comprehensive case evaluation to injured victims and their families.

 

Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-philips-ventilator-recall-most-serious-2022-01-26/

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