| Class 2 Device Recall RT Desktop | |
Date Initiated by Firm | November 25, 2013 |
Date Posted | March 06, 2014 |
Recall Status1 |
Terminated 3 on August 13, 2015 |
Recall Number | Z-1081-2014 |
Recall Event ID |
67217 |
510(K)Number | K982713 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | RT Desktop
The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. |
Code Information |
R4.2, R5.0, R5.1, R6.0, R6.1 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter Ne Ste 50 Atlanta GA 30346-1227
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For Additional Information Contact | Linda Wetsel 770-300-9725 |
Manufacturer Reason for Recall | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
FDA Determined Cause 2 | Software design |
Action | Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice
200 01 502 041 -
"Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of a mandatory upgrade to Integrity 1.2 upon its release which will prevent calibration from being inverted.
For questions regarding this recall call 770-300-9725. |
Quantity in Commerce | 489 |
Distribution | Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IYE
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