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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01318-1
Product Name/Description Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license)

ARTG Number: 102182, 102184
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 15/12/2014
Responsible Entity Siemens Ltd
Reason/Issue Siemens has identified a potential malfunction which can occur when composed images are flipped on the integrated imaging system FLOUROSPOT Compact. When composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. The affected images and associated annotations such as labels (e.g. R/L) may show incorrectly.

The corrupt image information might lead to an incorrect diagnosis.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.
Contact Information 1800 310 300 - Siemens Technical Support Centre