Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiati

FDA device recall Z-1082-2014 · posted 2014-03-06 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

IYE

Quantity affected

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,

Date initiated

2013-11-25

Date posted

2014-03-06

Date terminated

2021-09-15

Location

Atlanta, GA

Related 510(k) clearances