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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00361-1
Product Name/Description Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E
(fluoroscopic and standard diagnostic x-ray systems )

Catalogue Numbers: 10762470, 10762471

ARTG Numbers: 102184, 102182, 213886
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/04/2015
Responsible Entity Siemens Ltd
Reason/Issue Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:
· During an image recovery process on systems with portable detectors (MAX wi-D, MAX mini) the connection of the portable detector is sporadically not re-established.
· If either the “undo” button on the RAD subtask card or the “previous series” button on the Image subtask card are pressed during image readout.
· Sporadically, during an automatic or a manual RIS update. This may cause the deletion of the currently used study and all acquired images within this study.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing temporary instructions for users to follow to prevent the issues from occurring. A software update will be available in Q2 2015 which will permanently resolve the issue. This action has been closed-out on12/08/2016.
Contact Information 1800 310 300 - Siemens Technical Support Centre