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 Monacosee related information
Date Initiated by FirmMarch 05, 2012
Date PostedApril 03, 2012
Recall Status1 Terminated 3 on April 01, 2014
Recall NumberZ-1365-2012
Recall Event ID 61392
510(K)NumberK110730 
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
ProductMonaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
Code Information Version 3.10.00
Recalling Firm/
Manufacturer		 Computerized Medical Systems Inc
13723 Riverport Dr Ste 100
Maryland Heights MO 63043-4819
For Additional Information ContactChristopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall		An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
FDA Determined
Cause 2		Software design
ActionAn "IMPORTANT SAFETY NOTICE" was issued between 3/5-9/12 via e-mail, FAX, or traditional mail. The Notice described the correct functioning of the system, the problem, when and why the issue occurs, the clinical impact, and the workaround. Patch 3.10.01 is now available. Customers can download their patch at the link provided in the Notice. The Notice also provided a list of offices where customers can contact if they have questions or further support is needed.
Quantity in Commerce44
DistributionWorldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
-
-