Medical Device Recall
June 16, 2021Below is an important recall announcement for our pulmonary patients.
Philips Respironics is recalling the below devices due to two (2) issues.
- 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.
- 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.
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All Devices manufactured before 26 April 2021, All serial numbers |
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Continuous Ventilator |
Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent |
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Continuous Ventilator, Minimum Ventilatory Support, Facility Use |
A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto |
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Continuous Ventilator, Non-life Supporting |
A-Series BiPAP A40 A-Series BiPAP A30 |
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Continuous Ventilator, Minimum Ventilatory Support, Facility Use |
E30 (Emergency Use Authorization) |
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Continuous Ventilator, Non-life Supporting |
DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+ |
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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.