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U.S. Department of Health and Human Services

Class 2 Device Recall Multilead Collimator

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  Class 2 Device Recall Multilead Collimator see related information
Date Initiated by Firm November 25, 2013
Date Posted March 06, 2014
Recall Status1 Terminated 3 on November 08, 2017
Recall Number Z-1084-2014
Recall Event ID 67184
510(K)Number K121328  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Agility.
Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Code Information Model 3.0
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
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 Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 043 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Corrective Action #2 - Permanent Solution - All users of Integrity 3.1 software will be informed or a mandatory upgrade to Integrity 3.2 upon its release which will prevent calibration from being inverted. Target Release for Integrity 3.2 will be available at the end of February 2014.
Quantity in Commerce 300
Distribution Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
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 = IYE and Original Applicant = ELEKTA LTD.
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