iGUIDE Software 2 — Class II medical device recall Z-3017-2017
Terminated recall by Elekta, Inc., reported 2017-08-16, distributed in AK, CT, GA, HI, KY, LA, MA, MD…. Incorrect PEC values.
| Recall number | Z-3017-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2017-06-19 |
| Classified | 2017-08-10 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2019-11-05 |
| Distributed | AK, CT, GA, HI, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA |
| Countries outside the US | AT, AU, BE, CH, DE, DK, ES, FR, GB, HK, ID, IE, IN, IT, JP, NL, NZ, PL, SE, SI, VN |
| Quantity | 110 units |
Product
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Reason for recall
Incorrect PEC 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-3017-2017. 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.