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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00960-1
Product Name/Description Brainlab Patient Data Manager
(Used for the display of medical images or treatment / surgery plans from picture archiving and communication systems (PACS), file servers, or removable storage media)

Product Version Numbers
Content Manager (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0)
Patient Browser (versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.1.0)
DICOM Viewer (versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0)

ARTG Number: 96517
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/09/2015
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue When actively deselecting a fused reference dataset in Content Manager (the default setting is “selected”), a contained Point, Object or Trajectory may appear shifted and/or distorted in the subsequently used Brainlab navigation or planning software. If a reference dataset is deselected and the error occurs, the magnitude of shift or distortion varies, depending on the differences between the two datasets. Therefore, for some cases, the shift or distortion will be clearly visible when the plan is used in a Brainlab planning or navigation system. However, a shift could also be non-obvious. If a shift or distortion occurred and was not detected during review of the data, the deviation of the information displayed in the Brainlab planning or navigation software could mislead the user regarding clinical decisions. This could ultimately lead to ineffective treatment, serious injury or even death of the patient.
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab will provide a software solution to prevent the described scenario from occurring starting February 2016. In the interim, users are advised not to deselect individual datasets where a Point, Object or Trajectory was planned in. If users are unsure in which dataset a Point, Object or Trajectory was planned, do not deselect any content from the plan. Open the entire plan instead. Before patient treatment, always review the plausibility of all information input to and output from the device.
Contact Information 02 9424 3800 - Brainlab Australia