All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for action
Actions underway: 23 July 2019
Actions complete: 13 August 2019
Medical Device Safety Officer (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
All MX40 units are affected. The original expected battery life can be found in the instructions for use, section 15. This performance will be restored once the software is upgraded.
You can check which software version is installed on each monitor by touching the battery icon on the main screen, then selecting ‘Device Info’. The software version is listed under ‘Appl SW’.
showing how to check the software version.
Philips Customer Care Service Centre
Tel: 0870 532 9741
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Cardiac laboratory technicians
- Cardiac pacing technicians
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Community hospitals
- Coronary care departments
- Coronary care nurses
- Day surgery units
- EBME departments
- Equipment stores
- Equipment libraries and stores
- General surgery
- General surgical units, directors of
- In-house maintenance staff
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Medical directors
- Medical libraries
- Midwifery departments
- Midwifery staff
- MRI units, directors of
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- Operating department practitioners
- Ophthalmic nurses
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Purchasing managers
- Radiation & medical oncology departments
- Radiographer superintendents
- Renal medicine departments
- Renal medicine, directors of
- Resuscitation officers and trainers
- Special care baby units
- Theatre managers
- Theatre nurses
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/025 or 2019/004/011/291/024.
Tel: 020 3080 6000
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland Adverse Incident Centre (NIAIC)
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can’t access the webform, visit the website: how to report an adverse incident.
Population Healthcare Division, Welsh Government
Tel: 03000 250 986 / 03000 255 510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).