Intra-oral dental X-ray units: IRIX 70, IRIX 708, Oramatic 558 or Novelix 6510 – wall mount bracket may fail
- Medicines and Healthcare products Regulatory Agency
- 18 July 2013
- 18 July 2013
- Alert type:
- Medical device alert
(Trophy (now owned by Carestream Health)) Risk of injury from falling unit after failure of the wall mount bracket. (MDA/2013/053)
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.
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.
- 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.
- 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.
Carestream Dental Technical support team:
Telephone: 00 800 4567 7654
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)
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Dental departments
- Dental nurses
- Maxillofacial departments
- Medical physics departments
- Oral surgeons
- Radiographer superintendents
NHS England area teams
- General dental practices
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- 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: email@example.com and requesting this facility.
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.
David Grainger or Gica Leclerc
Medicines and Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
Telephone: 020 3080 7199 / 6610
Fax: 020 8754 3965
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
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
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
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
NHS National Services Scotland
1 South Gyle Crescent
Telephone: 0131 275 7575
Fax: 0131 314 0722
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Telephone: 029 2082 3922
Published: 18 July 2013
Issued: 18 July 2013
Alert type: Medical device alert