Data Foundry

Medical device recalls 2014

RT Desktop The EOS RT Desktop — Class II medical device recall Z-1081-2014

Terminated recall by Elekta, Inc., reported 2014-03-12, distributed in AL, CA, CT, FL, GA, IL, IN, KS…. During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect va

Recall numberZ-1081-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmElekta, Inc., Atlanta, GA, United States
Recall initiated2013-11-25
Classified2014-03-06
Reported by FDA2014-03-12
Terminated2015-08-13
DistributedAL, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA
Countries outside the USAR, AT, BD, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, GR, HU, ID, IL, IN, IR, IT, JP, KR, LB, MA, MX, NG, PA, PE, PH, PK, PT, RS, RU, SE, TH, TR, TW, VE, VN, ZA
Quantity489

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 for recall

During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1081-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.