Recall Z-1081-2014— Elekta, Inc.

Name: FDA recall Z-1081-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2013-11-25, terminated 2015-08-13. It names one FDA 510(k) clearance: K982713. 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2015-08-13
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K982713 — RT DESKTOPElekta Oncology Systems, Ltd.·cleared 1998-11-02

K-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

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 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.