National patient safety alertMHRA
ResMed Astral 100 and 150 Ventilators patient safety alert over a software fault
ResMed has issued a Field Safety Notice regarding Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured prior to October 2024. A fault in the device can cause unexpected interruption of ventilation therapy.
What to do now
The issue with ResMed Astral 100 and 150 Ventilators is in its software or user interface.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (NatPSA/2026/004/MHRA). Quoted as issued.
Summary
ResMed has issued a Field Safety Notice regarding Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured prior to October 2024. A fault in the device can cause unexpected interruption of ventilation therapy.
The risk
Date of Issue: 17 August 2026
Reference No: NatPSA/2026/004/MHRA
This alert is for action by: all Hospital Trusts, Health Boards and independent healthcare providers delivering NHS, community, home ventilation and private healthcare services. This is a safety critical and complex National Patient Safety Alert.
Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards).
Advice for healthcare professionals
1. Circulate the FSN within 2 working days to all relevant respiratory, critical care, paediatric, community ventilation and home ventilation services. Ensure relevant staff review and implement the actions described in the FSN .
2. Identify all affected Astral 100 and 150 ventilators and PCBA spare parts manufactured prior to October 2024, including devices used in community and home settings. Refer to Appendix B in the FSN to confirm affected serial numbers.
3. Within 1 month confirm that all affected ventilator-dependent patients have immediate access to a functioning backup ventilator or other emergency ventilation contingency arrangements.
4. Verify and document that carers and relevant staff are trained and competent to recognise ventilator alarms, implement emergency procedures and access urgent clinical support.
5. Clinicians should implement and document a patient-specific clinical risk assessment for all affected patients within 1 month , prioritising those who:
require ventilation for ≥14 hours per day
have a tracheostomy
are fully dependent on ventilation and/or unable to independently remove ventilation or summon assistance
are paediatric or otherwise clinically vulnerable
use devices approaching or beyond their expected service life
live in locations where emergency response may be delayed.
6. Contact the manufacturer to arrange a date of inspection for the affected devices according to the FSN and local risk prioritisation process.
Open the MHRA notice
Questions
Why has ResMed Astral 100 and 150 Ventilators been recalled?
The issue with ResMed Astral 100 and 150 Ventilators is in its software or user interface. Software faults can lead to wrong readings, missed alarms or incorrect settings.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.