iGUIDE System Product Usage: The intended use of the device is the… — Class II medical device recall Z-1807-2014
Terminated recall by Elekta, Inc., reported 2014-06-25, distributed nationwide. A bug in the software prevents the iGUIDE software from logging off.
| Recall number | Z-1807-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-05-29 |
| Classified | 2014-06-17 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2017-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CN, CO, DE, DK, DZ, ES, FI, FR, GB, HK, IN, IT, JP, KR, MX, NL, NZ, PE, PL, RU, SA, SE, TH, TW, VN |
| Quantity | 224 |
| Reason classes | software |
Product
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Reason for recall
A bug in the software prevents the iGUIDE software from logging off.
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-1807-2014. 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.