Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail

(Trophy (now owned by Carestream Health)) Risk of injury from falling unit after failure of the wall mount bracket. (MDA/2013/053)

Device

Intra-oral dental X-ray units:

IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510, manufactured by Trophy (now owned by Carestream Health). Models manufactured from November 1990 to November 1994 inclusive.

Problem

Risk of injury from falling unit after failure of the wall mount bracket.

The devices were subject to a modification in 1995 and 2000 to address this risk. However, we have received a number of reports of device failure where the maintenance instructions have not been followed, and the manufacturer has not been able to confirm that all affected devices have received the modification.

Action

  • Identify affected devices using the guidance detailed in the manufacturer’s field safety notice (FSN).
  • Check if the devices have been modified by following advice given in the FSN.
  • For devices that have not been modified, remove them from use and contact Carestream Health for assistance.
  • For all devices, ensure that they are maintained as recommended in Carestream’s service instructions.

Action by

  • Dentists
  • Community dental practices
  • General dental practitioners

Deadlines for action

Action underway: 1 August 2013, action complete: 15 August 2013

Note: These deadlines are for identifying affected devices and removing from use until modification is completed.

Manufacturer contact

Carestream Health
Carestream Dental Technical support team:
Telephone: 00 800 4567 7654

Email: europedental@carestream.com

Distribution

This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • Health and Safety Executive
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams
  • NHS 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 departments
  • Dental nurses
  • Dentists
  • Maxillofacial departments
  • Medical physics departments
  • Oral surgeons
  • Radiographer superintendents
  • Radiologists

NHS England area teams

  • General dental practices

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

This alert should be read by:

  • Clinics
  • General dental practices
  • 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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Contacts

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/053 or 2013/002/008/081/009.

Technical aspects

David Grainger or Gica Leclerc
Medicines and Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London
SW1W 9SZ

Telephone: 020 3080 7199 / 6610
Fax: 020 8754 3965

Email: david.grainger@mhra.gsi.gov.uk or gica.leclerc@mhra.gsi.gov.uk

For clinical aspects please contact the clinical team on 020 3080 7248 or 020 3080 7032

How to report adverse incidents

Please report via our yellowcard website

Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Northern Ireland

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
Telephone: 02890 523 704 Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic

Further information about the Safety Alert Broadcast System (SABS)

Scotland

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

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

Telephone: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

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

Telephone: 029 2082 3922

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

Download documents

MDA/2013/053: Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail

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