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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 System see related information
Date Initiated by Firm November 03, 2016
Create Date November 25, 2016
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-0660-2017
Recall Event ID 75664
510(K)Number K151233  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Code Information Software Builds 5.11 and 5.20
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-330-9725
Manufacturer Reason
for Recall		 Incorrect Dose when using the reset function.
FDA Determined
Cause 2		 Software design
Action Important Field Safety Notice 382-01-MON-006 was sent to all affected customers on 11/3/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. An acknowledgement form was included which is to be returned to Elekta.
Quantity in Commerce 671
Distribution AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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