Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 26 June 2017.
Contact the distributor to acknowledge receipt of the FSN and to arrange for the lower motor controller board to be replaced as soon as possible.
Medical and technical staff involved in the use and maintenance of these devices.
Deadlines for actions
Actions underway: 18 January 2018
Actions complete: 12 April 2018
Treadmills built before 06/06/2016 and with serial numbers lower than M300-1117 are affected.
SportsMed Products Ltd
Tel: 07891 251503
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:
- Biomedical engineering staff
- Cardiology departments
- Cardiac laboratory technicians
- EBME departments
- Equipment libraries and stores
- General surgery
- Maintenance staff
- Occupational therapists
- Rehabilitation engineers
- Risk managers
Establishments registered with OFSTED
- Hospitals in the independent sector
- Independent treatment centres
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 Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/037 or 2017/006/027/291/023.
Andy Marsden, MHRA
Tel: 020 3080 7205
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).