BiPAP A40 ventilators risk therapy loss during alarm condition
BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, establishing a minimum severity of 4. While deaths are not yet reported, the hazard involves loss of critical respiratory therapy that could lead to respiratory failure, hypoxemia, and death in vulnerable patients.
Plain-English summary
BiPAP A40 ventilators manufactured by Philips Respironics are subject to this Class I recall. Affected models include BiPAP A40, BiPAP A40 Pro, and BiPAP A40 EFL variants.
The devices may experience interruption or loss of therapy delivery during a Ventilator Inoperative alarm condition. This can lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure or insufficiency, and potentially death in vulnerable patients.
The recall affects 6 units in the United States and approximately 60,417 units outside the U.S. Worldwide distribution includes locations across Europe and other regions.
Patients and healthcare providers should contact Philips Respironics for information regarding this recall and remediation options.
The recalled product
- Product
- BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only)…
- Manufacturer
- Philips Respironics, Inc.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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