FDA Device recall Z-1081-2014
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/…
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/… by Elekta, citing during the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1081-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | AL, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA |
Product
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Reason
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Identifiers
| code_info | R4.2, R5.0, R5.1, R6.0, R6.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2014%22
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