Integrity — Class II medical device recall Z-1083-2014
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 number | Z-1083-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2017-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BR, CA, CH, CN, CO, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, MA, MX, MY, NG, NL, NO, NZ, PA, PE, PK, PL, PT, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 455 |
| Model numbers | 1.1 |
Product
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
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-1083-2014. 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.