Philips Recall of Previously Recalled, Repaired Ventilators Deemed Class I

The U.S. Food and Drug Administration (FDA) has identified Philips’ December 7 recall of certain reworked ventilators (Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators) that were also recalled in June 2021 as Class I.
 
BiPAP and CPAP machines reworked or replaced due to the recall in June 2021 are not affected by this new recall. Adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines.
 
The Trilogy and Garbin ventilators are used to provide breathing assistance to pediatric and adult patients. A ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen. Trilogy and Garbin ventilators are intended to be used in homes and health care settings, including when patients may be using a wheelchair or gurney.
 
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 or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life threatening.
 
Philips observed residual PE-PUR sound abatement foam in some reworked ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users.
 
As of January 4, there have been 82 MDRs (63 MDRs for foam delamination and 19 MDRs for particulate debris contamination) and no deaths.