Medical Device Recall

June 16, 2021

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Below is an important recall announcement for our pulmonary patients.

Philips Respironics is recalling the below devices due to two (2) issues.

1. PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, these particles may have short-term and long-term health effects.
2. The PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone and off-gassing may occur during operation.

All Devices manufactured before 26 April 2021, All serial numbers
Continuous Ventilator	Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting	A-Series BiPAP A40 A-Series BiPAP A30
Continuous Ventilator, Minimum Ventilatory Support, Facility Use	E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting	DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+
Noncontinuous Ventilator	SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstart SE Auto

Starling Physicians Department of Pulmonary has asked the Durable Equipment Companies (DME) to replace the machines for all affected patients.

Click here for more information from Philips.