COMPASS SW Version 3 — Class II medical device recall Z-1212-2015
Terminated recall by Iba Dosimetry Gmbh, reported 2015-03-04, distributed in AZ, GU, OK. Error in the software. During internal tests of the current development version of the Compass SW it was found
| Recall number | Z-1212-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iba Dosimetry Gmbh, Schwarzenbruck, N/A, Germany |
| Recall initiated | 2015-02-02 |
| Classified | 2015-02-26 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2015-08-18 |
| Distributed | AZ, GU, OK |
| Countries outside the US | AT, BR, CN, CO, 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 SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Reason for recall
Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
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-1212-2015. 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.