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U.S. Department of Health and Human Services

Class 2 Device Recall ERGO

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 Class 2 Recall
ERGO
see related information
Date Posted June 23, 2011
Recall Status1 Terminated on April 01, 2014
Recall Number Z-2645-2011
Recall Event ID 58206
Premarket Notification
510(K) Number
K080601 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.
Code Information ERGO++ Release 1.6.3 and 1.6.3.1
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
ERGO Release 1.6.3 is overestimating the MU values.
FDA Determined
Cause 2
DESIGN: Software Design
Action Computerized Medical Systems, Inc. sent an "USER NOTIFICATION" dated December 11, 2009, to all affected customers. The notice identified the product, problem and suggested a workaround to minimize the risk. The notice stated that this workaround does NOT substitute the need for regular Quality Assurance. Customers are instructed to review page 39 of user manual for further explanation of warnings. Customers were asked to complete the Notice for Customer section and return to 3D Line Medical System. This issue has been resolved in Release 1.7.0 and above. No follow-up notice will be distributed to customers. For further information please contact: CMS Software (314) 812-4460 (St Louis Office).
Quantity in Commerce 45
Distribution Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malaysia, Poland, Portugal, Serbia, and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = 3D LINE MEDICAL SYSTEMS S.R.L.
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