| 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 |
|
| 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 |