Check which version of the spreader bar your lifts have, using the manufacturer’s instructions in their Field Safety Notice (FSN).
If your device requires replacement, please stop using it immediately, quarantine it and contact Arjo UK.
If your device does not need replacement, fill in and return the customer response form in the FSN to Arjo UK to confirm this.
All those responsible for maintaining these medical devices.
Deadlines for actions
Actions underway: 27 February 2019
Actions complete: 29 July 2019
Medical Device Safety Officers (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.
Affected devices were manufactured between January 2008 and March 2010 inclusive, with serial numbers shown in Appendix A of the FSN. The label contains the manufacture date.
Arjo UK Ltd
Houghton Hall Business Park
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 departments
- A&E nurses
- Adult intensive care units
- All departments
- All staff
- All wards
- Clinical governance leads
- Community hospitals
- Equipment stores
- Equipment libraries and stores
- In-house maintenance staff
- Maintenance staff
- Medical libraries
- Occupational therapists
- Rehabilitation engineers
- Risk managers
- Supplies managers
Liaison officers for onward distribution to all relevant staff including:
- Back care/manual handling advisors
- Care at home staff
- Care management team managers
- Children’s disability services
- Community care staff
- Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
- Disability equipment stores
- Education departments for equipment held in schools
- Environmental health officers
- Equipment stores
- Equipment supplies managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
- Occupational health departments
- Occupational therapists
- Schools with hoists
- Transport managers
- Wheelchair and seating service managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- Further education colleges registered as care homes
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Establishments registered with OFSTED
- Children’s services
- Educational establishments with beds for children
- Residential special schools
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/2019/004 or 2018/011/023/601/005
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: 0208 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: 02920 823 624 / 02920 825 510
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).