Recall Z-1082-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
| Date | Mar 6, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. |
| Root cause | Software design |
| 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. |
| Quantity | 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, VA, WA, WV, WI, including Puerto Rico, DC; and countries of: Albania, Argentina, Australia, Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080585 | DESKTOP PRO Elekta , Ltd., Jun 11, 2008 |