BiPAP A30 00 (REF 1111144M)Recalls & reported problems
Respironics, Inc. · BiPAP A30 Medicair Respicomfort, Italy · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K113053); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 9, 2025Open, Classified
This device does not indicate for use in patients with respiratory failure.
Z-2036-2025 · Root cause: Device Design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K113053. One submission often covers many models, so check the product and lot details in each record.
- Z-1654-2022 · Aug 26, 2022 · Open, ClassifiedPhilips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Z-1957-2021 · Jun 14, 2021 · Open, ClassifiedA-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- Z-1973-2021 · Jun 14, 2021 · Open, ClassifiedDreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respiron
- Z-1958-2021 · Jun 14, 2021 · Open, ClassifiedA-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Other Ventilator, continuous, non-life-supporting devices
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING5 deaths547 reports
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths283 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, INTLRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING274 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths209 reports
- BiPAP S/T C-Series BiPAP S/T C Series Core Pack, 30cm, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death200 reports
- DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING4 deaths174 reports
- DreamStation BiPAP AVAPS DreamStation AVAPS30 w/Humid w/H Tube w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 deaths144 reports
- BiPAP A30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls29 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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