Data Foundry

Medical device recalls 2014

Desktop Pro TM linear accelerator control software intended to assist… — Class II medical device recall Z-1082-2014

Terminated recall by Elekta, Inc., reported 2014-03-12, distributed nationwide. During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect va

Recall numberZ-1082-2014
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
Terminated2021-09-15
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, LT, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SK, TH, TR, TW, UA, VE, VN, ZA
Quantity1,309

Product

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.

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-1082-2014. 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.