Monaco RTP System. Radiation treatment planning.
FDA Recall Z-0841-2013 · Posted 2013-02-20
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-02-11
Date Terminated2014-01-21
Product Quantity13
Reason for Recall
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Firm Action
Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.