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Philips Respironics, Inc. recalls BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 11
Recalled May 29, 2024 · FDA recall Z-1814-2024 · Philips Respironics
Hazard
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients. · FDA Class I
Units
3 US; 21,414 OUS
Sold at
Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
Description
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Product
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →