USFDA announces Class 1 recall for Philips ventilators

Washington DC – The U.S. Food and Drug Administration (FDA) said last week that it has classified the recall of certain reworked Philips ventilators as the most serious type, class 1, because their use may cause serious injuries or death.

Philips is recalling reworked Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators due to potential for silicone foam adhesion failure and residual PE‐PUR foam debris.

These ventilators are used to provide breathing assistance to both children and adult patients.

The FDA said Philips is recalling the devices due to two reasons: The silicone sound abatement foam installed to replace PE-PUR foam may separate from the plastic backing due to adhesive failure. The silicone foam material may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. If an alarm is not recognized, the patient could experience trouble breathing which could be life threatening.

In addition, Philips observed residual PE‐PUR sound abatement foam in some reworked ventilators which were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, according to the FDA.

The agency noted that as of Jan. 4, there have been 82 medical device reports (MDRs) (63 MDRs for foam delamination and 19 MDRs for particulate debris contamination) and no deaths.

The FDA said that this recall is for certain reworked ventilators that were also recalled in June 2021.

BiPAP and CPAP machines reworked or replaced due to the recall in June 2021 are not affected by the new recall. Adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines, according to the FDA.

Philips is reeling under the impact of recall of certain of its respiratory devices due to potential safety issues which has been going since early 2021.