Medical Device Alert: Radiology information system (IMPAX 6.x) when used in conjunction with Voxar 3D software suite (MDA/2009/048)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/048 or 2009/004/022/401/016

Technical aspects
David Grainger or Paul Sandhu
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3199/3266
Fax: 020 7084 3209
E-mail:
david.grainger@mhra.gsi.gov.uk
paul.sandhu@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

E-mail: susanne.ludgate@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

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 SABS can be found at http://sabs.dhsspsni.gov.uk

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

E-mail: nss.iric@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

Risk of incorrect or delayed treatment or diagnosis.

Multi-planar reformat imaging data created by Voxar 3D may be lost by Agfa IMPAX system during transfer.

It has been reported that occasionally IMPAX does not save all report captures from Voxar 3D.

There is no loss of original data and users will always be able to create new reconstructions.

This issue has only been observed on systems which have the Voxar 3D workstation software version 5.1 integrated with IMPAX workstation versions 6.x.

For customers using early versions of IMPAX 6.x who wish to keep using the earlier versions of Voxar (including Voxar 5.1) Agfa recommends upgrading to IMPAX 6.2.1 SU17 to avoid this issue.

Dates when Voxar 3D 5.1 was integrated with the various IMPAX revisions:

• IMPAX 6.0 – end of 2004
• IMPAX 6.01 – end of 2005

PACS managers

• Have plans in place to ensure that end users are made aware of the issue.
• Contact Agfa to discuss upgrade solution.

Users of IMPAX:

• Have procedures in place to verify that the entire relevant data set is available before beginning treatment.
• Consider the need for clinical review of outcomes of procedures relying on multiplanar reformats from IMPAX.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• 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 and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Clinical governance leads
• Day surgery units
• EBME departments
• ENT medical staff
• General surgeons
• Health and safety managers
• Medical directors
• Orthopaedic surgeons
• Outpatient departments
• PACS managers
• Radiographer superintendents
• Radiologists
• Risk managers
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Independent treatment centres

Mark Carter
Agfa HealthCare UK Limited
Vantage West
Great West Road
Brentford
TW8 9AX

Tel: 020 8231 5984 or 07831 133 942 (direct line)
Fax: 0800 163 813

E-mail: mark.carter@agfa.com