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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01233-1
Product Name/Description All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015

Giraffe Incubator Carestation
Serial Numbers: TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, TAAU67011, TAAU67012

Giraffe OmniBed Carestation
Serial Numbers: TABU67001, TABU67002, TABU67003, TABU67005, TABU67006, TABU67007, TABU67008, TABU67009, TABU67011

ARTG Number: 139289
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/12/2015
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue If the Clear Patient History prompt is not responded to, the previous patient's weight could be displayed on the Giraffe Carestation user interface.
This could cause clinical decisions to be made based on the weight associated with the wrong patients, which in turn could lead to clinical decisions which could require medical intervention.
There have been no injuries reported as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is providing work around instructions for users to follow as an interim measure. A software upgrade will be provided as a permanent correction. This action has been closed-out on 29/08/2016.
Contact Information 1800 659 465 - National Call Centre