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U.S. Department of Health and Human Services

Class 2 Device Recall Monaco Radiation Treatment Plan

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 Class 2 Device Recall Monaco Radiation Treatment Plansee related information
Date Initiated by FirmJuly 26, 2021
Create DateSeptember 02, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2406-2021
Recall Event ID 88451
510(K)NumberK183037 K190178 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductMonaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Code Information Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
Recalling Firm/
Manufacturer		 Elekta Inc
1450 Beale St Ste 205
Saint Charles MO 63303
For Additional Information ContactMark Roman
314-993-0003
Manufacturer Reason
for Recall		If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
FDA Determined
Cause 2		Under Investigation by firm
ActionElekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt. This issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.
DistributionDistribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom
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
510(K)s with Product Code = MUJ
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