BiPAP A40 ESX3000S19Recalls & reported problems

Respironics, Inc. · BiPAP A40 EFL, Spain · Class 2

All models of BiPAP A40 (37)

Data updated Oct 16, 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.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Mar 26, 2024Open, Classified
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.
Z-1813-2024 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`00606959058927`
Brand	BiPAP A40
Model	ESX3000S19
Company	Respironics, Inc.
Product code	MNT · Ventilator, continuous, minimal ventilatory support, facility use
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2023

Device type (GMDN): Portable electric ventilator

A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Other Ventilator, continuous, minimal ventilatory support, facility use devices

Philips Respironics V60
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3 recalls30 deaths13,525 reports
PHILIPS 1076716
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2 recalls1 death2,946 reports
PHILIPS 1076709
Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
8 deaths2,174 reports
PHILIPS 1053614
Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
2 recalls4 deaths1,203 reports
BiPAP A40 EEX3100S19
Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
2 recalls422 reports
BiPAP A40 DEX3100S13
Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
2 recalls164 reports
BiPAP A40 ITX3100S21
Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
2 recalls163 reports
PHILIPS 1053613
Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use
2 recalls1 death161 reports

All Ventilator, continuous, minimal ventilatory support, facility use devices →

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 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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