UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems - identify affected devices and remove from service immediately

(MECALL Srl) an X-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time. (MDA/2009/014)

23 February 2009 at 14:30

MDA/2009/014

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 02 March 2009, Deadline (action complete): 23 March 2009

Device

UNISTAT L floor stand for diagnostic X-ray and superficial X-ray therapy systems.

These stands were manufactured between 1990 and 2000.

See attachment for suppliers, serial numbers and location of serial number label.

Problem

The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously. The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination.

The X-ray tube head is supported by a metal rope that winds over a pulley system behind the tube support covers. There is a safety device fitted, which should catch the rope if it breaks.

Wear on the cable may go undetected as the current service instructions for this device do not require that the whole length of the cable is inspected nor do they require that the ‘safety device’ is inspected.

The manufacturer has updated the service instructions and issued a Field Safety Notice, available to download from:

X-ray, ancillary equipment and accessories - Mecall Srl - UNISTAT L floor stand.

Action

  • Identify any affected devices.
  • Immediately remove from service.
  • Contact the manufacturer.
  • Ensure that the whole length of the support cable and the ‘safety device’ are inspected following the updated service instructions and are free from defect before returning into service.

Action by

All healthcare workers who use or maintain these devices.

Distribution

This MDA has been distributed to:

  • NHS trusts in England (Chief Executives)
  • Healthcare Commission (CHAI) (Headquarters)
  • NHS Boards in Scotland (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 liaison officers for onward distribution to all relevant staff including:

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

Healthcare Commission (CHAI) to: Headquarters for onward distribution to:

  • Hospitals in the independent sector
  • Independent treatment centres

Change of address or removal from address list for Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

Contacts

Manufacturer contact

Manufacturer

Luigi Besana
Safety and Regulatory Manager
MECALL S.r.l.
Via Negrelli 55
20035 Lissone (Mi)
Italy

Tel: +39 039 243 1525
Fax: +39 039 464 819

Email:    lbesana@mecall.it

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/014 or 2008/012/030/401/007.

Technical aspects

David Grainger or Jim Lefever
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3199 / 3262
Fax: 020 7084 3209

Email:  david.grainger@mhra.gsi.gov.uk or jim.lefever@mhra.gsi.gov.uk

Clinical aspects

Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3123
Fax: 020 7084 3111

Email:    susanne.ludgate@mhra.gsi.gov.uk

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 (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

Scotland

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

Wales

Enquiries in Wales should be addressed to:

National Assembly for Wales
HIMTE 3 Division
NHS Directorate
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3373
Fax: 029 2082 5479

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

Download documents

[InlineAttachment:con297518.pdf]

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