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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco RTP System

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 Class 2 Device Recall Monaco RTP Systemsee related information
Date Initiated by FirmJuly 03, 2019
Create DateJuly 27, 2019
Recall Status1 Open3, Classified
Recall NumberZ-2091-2019
Recall Event ID 83273
510(K)NumberK151233 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductMonaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Code Information all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
Recalling Firm/
Manufacturer		 Elekta Inc
13723 Riverport Dr Ste 100
Maryland Heights MO 63043-4819
For Additional Information ContactAlejandra Carrillo
404-202-4333
Manufacturer Reason
for Recall		When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
FDA Determined
Cause 2		Under Investigation by firm
ActionElekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue. The problem will be resolved in a future Monaco software release.
Quantity in Commerce1396 units
Distributionworldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MUJ
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