Elekta ERGO++ Product Usage: ERGO is often used for stereotactic… — Class II medical device recall Z-0234-2018
Terminated recall by Elekta Inc, reported 2017-12-20, distributed nationwide. Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect ro
| Recall number | Z-0234-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Maryland Heights, MO, United States |
| Recall initiated | 2017-09-01 |
| Classified | 2017-12-12 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2019-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, BG, BR, CA, CO, CZ, DE, EC, ES, FR, GR, HK, IE, IN, IT, JO, JP, KR, MX, MY, NL, NZ, PE, PH, PT, RU, SA, SG, TH, TR, TW, VE, VN |
| Quantity | 182 |
Product
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Reason for recall
Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
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-0234-2018. 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.