Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Monaco

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Monaco see related information
Date Initiated by Firm April 16, 2020
Create Date April 29, 2020
Recall Status1 Open3, Classified
Recall Number Z-1825-2020
Recall Event ID 85425
510(K)Number K183037  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Code Information Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)
Recalling Firm/
Manufacturer		 Elekta Inc
1450 Beale St Ste 205
Saint Charles MO 63303
For Additional Information Contact Mark Roman
314-993-0003
Manufacturer Reason
for Recall		 The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
FDA Determined
Cause 2		 Software design
Action In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose should be investigated by the customer/user. The customer/user should post the issued notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and to advise the appropriate personnel who are working with this product on the content of this letter. Customers/users are also required to either acknowledge receipt of this notification via the Elekta Care Community or complete the provided acknowledgement form and return it to Elekta immediately upon receipt, but no later than within 30 days of receiving the notification letter.
Quantity in Commerce 96 devices
Distribution Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MUJ and Original Applicant = Elekta, Inc
-
-