Recall Z-1082-2014— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2021-09-15. It names one FDA 510(k) clearance: K080585. Product: Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.. Reason: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-25
- Terminated
- 2021-09-15
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Reason for recall
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Data sourced from openFDA. This site is unofficial and independent of the FDA.