Medical Device Alert: GE patient tables for use with GE X-ray systems (MDA/2010/005)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/20010/005 or 2009/009/014/291/022.

Technical aspects
Paul Sandhu or David Grainger
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3266/3199
Fax: 020 7084 3209

Email: paul.sandhu@mhra.gsi.gov.uk or david.grainger@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link). Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link)

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

Email: Haz-Aic@wales.gsi.gov.uk

Unexpected movement of the floating tabletop due to failure of the brake mechanism. There is a risk of injury as a patient may lose balance when getting on or off the table.

Ensure that:

• all affected devices are identified
• a site visit is arranged with GE to replace the tabletop floating control mechanism
• all users are made aware of this problem and that they always check the tabletop is locked before the patient is moved on to or off the table.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Directors of radiology
• Medical directors
• Radiation and medical oncology departments
• Radiographers
• Radiologists
• Radiology departments
• Risk managers
• Superintendent radiographers

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector

Nicholas Davies
Modality Leader Xray
GE Healthcare
352 Buckingham Avenue
Slough
SL1 4ER

Tel: 01753 874043
Fax: 01753 417098

Email: nick.davies@med.ge.com