Company: Elekta Inc.
Date of Enforcement Report: 9/10/2014
Class lI:
PRODUCT
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Recall Number Z-2581-2014
REASON
When DICOM’s exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
RECALLING FIRM/MANUFACTURER
Elekta, Inc., Atlanta, GA on 8/18/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
928 Units
DISTRIBUTION
Nationwide and internationally
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