COMPASS — Class II medical device recall Z-0168-2015
Terminated recall by Iba Dosimetry Gmbh, reported 2014-11-12, distributed in GU. Error in the software. A deviation between reconstructed and planned dose distribution may not be detected pri
| Recall number | Z-0168-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iba Dosimetry Gmbh, Schwarzenbruck, N/A, Germany |
| Recall initiated | 2014-09-25 |
| Classified | 2014-11-04 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2015-01-26 |
| Distributed | GU |
| Countries outside the US | AT, BR, CN, DE, DZ, ES, FI, FR, GB, HK, IN, JP, KR, MX, MY, NL, PA, PH, PL, RU, SG, TH, TR, TW, VE, ZA |
| Quantity | 124 units |
| Reason classes | software |
| Model numbers | CS10-100 |
Product
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Reason for recall
Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
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-0168-2015. 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.