Integrity 1 — Class II medical device recall Z-1322-2014
Terminated recall by Elekta, Inc., reported 2014-04-09, distributed nationwide. The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam del
| Recall number | Z-1322-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2014-04-02 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2017-07-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FR, GB, GR, HK, HN, HR, ID, IE, IN, IQ, IT, JO, JP, KR, MA, MX, MY, NG, NL, NO, NZ, PA, PE, PK, PL, RO, RU, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 498 |
Product
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Reason for recall
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
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-1322-2014. 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.