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MDA/2006/009 - Toshiba ultrasound scanner - Aplio 50, Aplio 80 and Xario

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/009
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 14 February 2006 at 14:15
Ref: MDA/2006/009

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Toshiba ultrasound scanner - Aplio 50, Aplio 80 and Xario

 >Page 2

Problem:
The TI (thermal index) is not displayed in B mode (2D mode) due to a software error. This can lead to an unknown increase in local temperature in the patient and difficulties in applying the ALARA (As Low As Reasonably Achievable) principle.

 >Page 2

Action by:
Radiologists, radiographers, sonographers, other users and equipment managers of the above devices.

  

Action: 

  • Be aware that the TI will not be displayed in B mode and can be greater than 1.
  • Contact the manufacturer to arrange a software upgrade that will correct the problem.
  • Follow the manufacturer's request to use the system referring to the maximum TI values for B mode given in the 'Acoustic Power and Surface Temperature Data' section of the Aplio manual 2B730-707 and Xario manual 2B730-686 until the upgrade has been completed.
  

Distributed to:

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

* via CE Bulletin

 >Page 2
Contacts:

Details of manufacturer and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

 >Page 3


ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS)
Deadline (Action underway): 02 March 2006 Deadline (Action complete): 13 March 2006


 

Page last modified: 14 February 2006