—#124887

Product

Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K112613
Affected lot / code info: Model 1.1

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-11-25
Posted by FDA: 2014-03-06
Terminated: 2017-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.