BiPAP A40 ventilators are not indicated for respiratory failure patients
The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.
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: FDA Class I recall, which the rubric floors at Severe; no death or injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The BiPAP A40 Ventilator, used to provide noninvasive ventilation support for adult and pediatric patients, together with the BiPAP A40 Pro sold outside the United States, is being recalled. The action covers 6 units in the US and 67,534 units outside it, identified by the serial numbers in the recall notice.
The stated reason is that this device does not indicate for use in patients with respiratory failure. The FDA classified the action as Class I, its most serious classification.
US units carry material number 1111169 and UDI-DI 00606959039476. Distribution was worldwide, including nationwide in the United States with Guam and Puerto Rico, and to the United Arab Emirates, Argentina, Austria, Australia, Bosnia and Herzegovina, Belgium, Brazil, Canada, Chile and other markets.
Facilities should identify affected units using the material number, UDI-DI and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
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.
- Category
- Medical Device — Ventilator
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.
See all 3 products in this recall →Related recalls
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Same hazard · indication limitation
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