iba COMPASS SW Version 3 — Class II medical device recall Z-0456-2014
Terminated recall by Iba Dosimetry Gmbh, reported 2013-12-18, distributed in CA, CT, MA, NY, OH, OK, SC. The development partner of IBA informed that there is problem in a SW component used in COMPASS when convertin
| Recall number | Z-0456-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iba Dosimetry Gmbh, Schwarzenbruck, Germany |
| Recall initiated | 2013-08-20 |
| Classified | 2013-12-06 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-02-24 |
| Distributed | CA, CT, MA, NY, OH, OK, SC |
| Countries outside the US | CA, CN, DE, ES, HK, MX, NL, PL, SG, TR |
| Quantity | 33 units |
| Model numbers | CS10-100 |
Product
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Reason for recall
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
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-0456-2014. 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.