Intra-oral dental X-ray units: Kodak 2100 and Kodak 2200 - risk of injury
(Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)
CAS deadlines: action underway
10 March 2014, action complete: 24 March 2014
Note: These deadlines are for systems to be in place to identify affected units and plan any appropriate actions
Device
Image of Intra-oral dental X-ray unit.
Intra-oral dental X-ray units:
Kodak 2100 and Kodak 2200 (wall and ceiling mounted)
Manufactured by Carestream Health
Models released for sale from May 2008 to April 2010, serial numbers as identified in the FSN.
Problem
Risk of injury if the joint between the scissor arm and bracket fails.
This joint could fail prematurely due to a manufacturing problem during the period from May 2008 to April 2010.
Action
- Identify affected devices using the guidance in the manufacturer’s (195Kb) (FSN).
- Inspect the units using the pictures in the FSN, to ensure the arm has not failed.
- If the unit shows signs of failure, stop using it and call your dealer immediately.
- All systems need to be inspected even if they don’t show signs of failure.
- Contact your dealer to arrange a service engineer visit.
Action by
- Dentists.
- Community dental practices.
- General dental practitioners.
Distribution
This MDA has been sent to:
- Care Quality Commission (CQC) (headquarters) for information
- Clinical commissioning groups (CCGs)
- 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:
- Community dental practices
- Dental departments
- Dental nurses
- Dentists
- In-house maintenance staff
- Maxillofacial departments
- Medical physics departments
- Oral surgeons
- Radiographer superintendents
- Radiology departments
- Radiology directors
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General dental practitioners
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.
Feedback
If you have any comments or feedback on this Medical Device Alert please email us at:dts@mhra.gsi.gov.uk.
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2014/005 or 2014/001/013/081/022
Technical aspects
David Grainger or Ian Sealey
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7199 / 6691
Fax: 020 8754 3965
Email: david.grainger@mhra.gsi.gov.uk or ian.sealey@mhra.gsi.gov.uk
Clinical aspects
Mark Grumbridge
Medicines & Healthcare Products Regulatory Agency
Floor 4, 151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7128
Fax: 020 8754 3965
Email: mark.grumbridge@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
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
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
Further information about SABS can be found on the SABS website
Scotland
All requests regarding return, replacement or modification of the devices mentioned in this alert should be directed to the relevant supplier or manufacturer.
Other 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
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Incident Reporting and Investigation Centre
Wales
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 5801
Email: Haz-Aic@wales.gsi.gov.uk
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