| Class 2 Device Recall Desktop Pro TM and Desktop Pro (VMAT) | |
Date Initiated by Firm | November 25, 2013 |
Date Posted | March 06, 2014 |
Recall Status1 |
Terminated 3 on September 15, 2021 |
Recall Number | Z-1082-2014 |
Recall Event ID |
67223 |
510(K)Number | K080585 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. |
Code Information |
Identifier - 6.0, 6.1.0, 7.0.1 |
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 | Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 040 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. All software versions (r7.01) detailed in this notice are affected by this recall. 200 01 501 041 - Recommended quality assurance after a calibration procedure Released November 25, 2013. Only software versions R6.0 and R6.1 are affected by this recall. Important Field Safety Notices are 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. |
Quantity in Commerce | 1309 |
Distribution | Worldwide Distribution: US (nationwide): AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia & Herzego, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore Slovakia, South Africa, South Korea, Spain, Sudan, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam. |
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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