Medical Device Alert: Non CE-marked portable dental X-ray units including the Tianjie Dental ‘Falcon’ (MDA/2012/046)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/046 or 2012/006/025/081/008.

Technical aspects
David Grainger or Paul Sandhu
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7199 or 7266
Fax: 020 8754 3965
Email: david.grainger@mhra.gsi.gov.uk or paul.sandhu@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 6648
Fax: 020 8754 3965
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 CAS 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
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

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 (IRIC) (external link)

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk

Testing by the Health Protection Agency (HPA) has revealed that the Tianjie Dental Falcon device lacks sufficient shielding in the X-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the Ionising Radiation Regulations 1999 annual dose limits. This could give rise to adverse health effects caused by radiation.

The Tianjie Dental Falcon is not CE-marked as a medical device.

• Identify and stop using this and similar non CE-marked devices.
• Replace the device with a suitable CE-marked alternative.
• Be aware of the NRPB (HPA) Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment or the Medical & Dental Guidance Notes published by IPEM.
• Be aware of the general requirement to consult a suitable radiation protection adviser with regard to the use of X-ray equipment.
• Be aware of MHRA advice on the use of non-CE marked devices.
• Report any suspected devices to MHRA Adverse Incident Centre.

Action by

Dentists, Medical Physics Departments

This MDA has been sent to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (Headquarters) for information
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (equipment coordinators)
• Local authorities in Scotland (equipment coordinators)
• NHS boards and trusts in Wales (chief executives)
• Health and Safety Executive
• Primary care trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.  Below is a suggested list of recipients.

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

• Dental Hospitals
• Dentists
• Orthodontists
• Medical physics departments
• Radiographer superintendents
• Radiographers
• Radiologists
• EBME Departments
• Supplies departments

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

• Community dental practices
• Directors of public health
• General dental practitioners
• Maintenance staff

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Hospitals in the independent sector
• Dental Practices

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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Lin Lin
Zhengzhou Tianjie Electronic Equipment Co
No 3 Youai Road
Zhengzhou City
Henan Province
P.R. China

Tel:    +86 371 67934274
Fax:   +86 371 67375396
website: http://www.tianjiedental.com/contact.html

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

Appendix: Non CE-marked portable dental X-ray units including the Tianjie Dental ‘Falcon’(MDA/2012/046) (622Kb)