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Spacelabs Ultraview Digital Telemetry Transmitter Model 90478

Notice type: Warning

Date: 20/04/2009

  

Product name or type:
Spacelabs Ultraview Digital Telemetry Transmitter Model 90478.

Reference:
IMB Safety Notice SN2009(02)

Manufacturer Or Supplier:
Spacelabs Healthcare Limited

Target Audience:
Risk Managers
Purchasing Managers
Clinical Engineering / Medical Physics

Problem Or Issue:
Spacelabs Healthcare issued an ‘Urgent – Medical Device Correction’ letter in August 2008 advising all customers of several circumstances where the device alarm may fail.

Background Information Or Related Documents:
Spacelabs Healthcare issued an ‘Urgent – Medical Device Correction’ letter in August 2008 advising all customers of several circumstances where the device alarm fails.  It also advised customers of new software V3.05.7 EN that would be provided to correct the problem. 

The affected devices were supplied to the Irish market by Hospital Services Limited and Fannin Healthcare. 

Hospital Services Ireland has been coordinating this action in Ireland.  However, despite several rounds of communication, they have experienced problems locating all of the affected devices.  A significant number of devices still require the software upgrade.

Spacelabs Ultraview Digital Telemetry Transmitter Model 90478 Document

Actions To Be Taken:
  • Ensure that the appropriate personnel are made aware of this notice.
  • Advise Hospital Services Ireland of the number and location of all affected devices in your hospital / health board. 
  • Ensure that the software upgrade is completed on all devices.

Further Information:

All adverse incidents relating to a medical device should be reported to the:

Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone:  +353-1-6764971
Fax:  +353-1-6344033


Enquiries to the manufacturer should be addressed to:

Barry Cripps 
Spacelabs Healthcare Limited
Beech House, Chiltern Court

Asheridge Road, Chesham
Buckinghamshire HP5 2PX
United Kingdom 

Telephone:  +44-1494-784422
Fax:  44-1494-794414


BrianCrotty
Hospital Services Limited

Telephone:  +353-1-2950500
E-mail:  brian.crotty@hsl.ie

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