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MDA/2007/083 - General ultrasound scanner: Nemio and Nemio XG systems manufactured by Toshiba Medical Systems Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/083
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 31 October 2007 at 11:00
Ref: MDA/2007/083

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request

 

Device:
General ultrasound scanner: Nemio and Nemio XG systems manufactured by Toshiba Medical Systems Ltd.

>Page 2

Problem:

  • A software error has been identified which can lead to an increased transducer tip temperature and an increased thermal index, along with incorrectly displayed MI (mechanical index) and TI (thermal index) values.
  • Some of the acoustic power values in the manual are incorrect.

>Page 2
Action by:
Radiologists and radiographers.		  

Action:

  • Identify implicated devices (see device section overleaf).
  • Ensure you have been contacted by the manufacturer to arrange for a software upgrade and replacement user manuals.
  • Follow guidance given by Toshiba to ensure the safe use of the device in the interim before the software upgrade is performed (see appendix).
 

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

>Page 2
Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3
Appendix:
Manufacturer’s customer letter.		  >Pages 4-5


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 7 November 2007
Deadline (action complete): 21 November 2007

Page last modified: 31 October 2007