BiPAP A40 Ventilator Recalled for Improper Respiratory Failure Patient Use
Philips Respironics BiPAP A40 ventilators are being recalled because they are not indicated for use in patients with respiratory failure. The device may not be appropriate for this patient population.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class I classification indicates serious safety concern. However, no illnesses or injuries have been reported, and the hazard is an improper indication issue representing theoretical risk of harm rather than a confirmed product defect with reported adverse events. Per the rubric, this qualifies as High severity for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Respironics is recalling BiPAP A40 ventilators that provide noninvasive ventilation support to adult and pediatric patients. The devices are distributed worldwide.
The recall is being issued because the device is not indicated for use in patients with respiratory failure. The FDA has classified this as a Class I recall, indicating a serious safety concern.
In the United States, 6 units have been distributed (including Guam and Puerto Rico). Worldwide, 67,534 additional units have been distributed outside the United States. Patients and healthcare providers using or considering this device should contact Philips Respironics for further guidance and information about appropriate alternatives.
The recalled product
- Product
- BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- improper-indication
- respiratory-failure
Distribution
Distributed nationwide across the United States.
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