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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00031-1
Product Name/Description	Kodak DirectView DR 7500 System with software version 5.3 (diagnostic x-ray system) ARTG Number: 136112
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/01/2014
Responsible Entity	Carestream Health Australia Pty Ltd
Reason/Issue	There were two incidents in the United States where the previous patient image was displayed on the console with the current patient's name. Carestream Health has determined that this only occurs when the user interrupts the daily offset refresh detector calibration by switching the active detector from one Bucky to another (e.g. table to the wall) and cancels detector calibration within 30 seconds of initiating this process. There have been no reports of misdiagnosis or injuries related to this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Carestream Health is recommending that the daily detector calibration process should not be interrupted once initiated and completed only when patients are not being imaged. Carestream Health is installing the software modification as a permanent correction.
Contact Information	02 8962 4914 - Carestream Health Australia