Recall Z-1322-2014 · IYE Accelerator, Linear, Medical

Elekta, Inc.

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

Date	Apr 2, 2014 (initiated Mar 28, 2013)
Status	Terminated
Reason	The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
Root cause	Software design
Action	An Important Field Safety Notice (IFSN) has been released and distributed to all customers. Integrity 1.1 Incorrect Static Tolerances for Linac Geometric Axes, 200 01 502 032. The notice explains the issue and that the user should apply the static Tolerance Updater tool to check tolerances and adjust as required. Important Field Safety Modification Digital Accelerator FCO Ref: 200 02 502 031 Integrity R1.1 Static Tolerance Updater Tool was released 03-2013. Elekta has released Integrity version 1.2 which contains the permanent fix for this issue. The permanent solution fixes the error tha
Quantity	498
Distribution	Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia,
FDA record	Open on fda.gov

510(k) clearances named in this recall

K112613

INTEGRITY(TM)
Elekta Limited, Dec 16, 2011