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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00670-3
Product Name/Description Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)

Elekta Monaco rel. 3.10.00 through 3.20.00
ARTG Number: 186856

Focal rel. 4.64.00 through 4.70.00
ARTG Number: 186853
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/07/2012
Responsible Entity Elekta Pty Ltd
Reason/Issue IF the DICOM coordinates option is turned on in the Reports pull down menu the following issues are seen on the resulting print out:
Issue 1: The coordinates will be in DICOM space, thus not matching the Setup Reference dialogue.
Issue 2: The shift coordinates are reported incorrectly. The Z coordinate should become DICOM negative Y and the Y coordinate should become DICOM Z.
Incorrect shift coordinates are generated based on Issue 2 above. These shifts can lead to incorrect patient positioning prior to treatment position verification.
Recall Action Recall for Product Correction
Recall Action Instructions Customers to implement the work around instructions provided by the sponsor until the problem is resolved with the future release of a software patch. This action has been closed-out on 12/02/2016.
Contact Information 02 8907 1800 - Elekta Regulatory Affairs