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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00970-1
Product Name/Description DRX Revolution Mobile, DRX Mobile Retrofit & DRX Transportable X-ray Systems

All lot numbers affected

ARTG Numbers: 194055 & 161988
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/09/2013
Responsible Entity Carestream Health Australia Pty Ltd
Reason/Issue Carestream Health Australia has received reports from overseas of unusable diagnostic images on exams where a Normal Exposure Mode (NEM) view is exposed immediately prior to an Extended Exposure Mode (EEM) view with the system in Fast Preview Mode.
Recall Action Recall for Product Correction
Recall Action Instructions Carestream Health Australia is providing a firmware update that will allow NEM and EEM images to be taken in any order. The update will be provided at the next scheduled service or within 3 months. Until the firmware upgrade is installed end users are advised to only perform the EEM acquisition prior to the NEM acquisition.
Contact Information 02 8962 4914 - Carestream Health Australia