Food, drugs, devices › Elekta, Inc.
Device recall: Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiati
FDA enforcement event 67223 is a device recall by Elekta, Inc. of Atlanta, GA, initiated 25 Nov 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 15 Sep 2021. Initiation: voluntary: firm initiated. Elekta, Inc. has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Elekta, Inc., Atlanta, GA.
Reason for recall
"During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1082-2014 | Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. | 1309 | Class II | Terminated | 12 Mar 2014 |
Context
Other enforcement events for Elekta, Inc.
All 105 events for Elekta, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Sep 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.