Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerato

FDA device recall Z-1322-2014 · posted 2014-04-02 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.

Action taken

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 that made the digital accelerator protection functions use the value loaded from the calibration database. The solution now ensures the protection functions use the values the digital accelerator calculates. Important Field Safety Notice 200 01 502 035 has been released to inform customers the solution is available. Important Field Safety Modification 200 02 502 036 will track the installation of the software by Elekta service engineers.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

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,

Date initiated

2013-03-28

Date posted

2014-04-02

Date terminated

2017-07-26

Location

Atlanta, GA

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