iGUIDE System with software build iGuide 2 — Class II medical device recall Z-2230-2019
Terminated recall by Elekta, Inc., reported 2019-08-21, distributed nationwide. Potential for iGUIDE to incorrectly monitor the 3D position.
| Recall number | Z-2230-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2019-06-19 |
| Classified | 2019-08-09 |
| Reported by FDA | 2019-08-21 |
| Terminated | 2024-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EG, ES, FR, GB, HK, ID, IE, IL, IN, IT, JO, JP, KR, MA, MX, MY, NL, NO, NZ, PL, PT, RO, SE, SK, TH, TR, TW, VN, ZA |
| Quantity | 374 devices |
| UPC / GTIN / UDI-DI | 04056719001704, 04056719001742, 04056719002039 |
Product
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Reason for recall
Potential for iGUIDE to incorrectly monitor the 3D position.
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-2230-2019. 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.