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Terminated

Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Recall Z-1082-2014 · Posted 2014-03-06

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-11-25
Date Terminated2021-09-15
Product Quantity1309

Reason for Recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080585DESKTOP PROElekta , Ltd. · 2008-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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