Class II — Iba Dosimetry Gmbh
| Recalling firm | IBA Dosimetry GmbH |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological |
| Quantity | 124 units |
| Distribution | Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam. |
| Initiated | 2015-02-02 |
| Classified | 2015-02-26 |
| Terminated | 2015-08-18 |
| Recall number | Z-1212-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Iba Dosimetry Gmbh (Z-1212-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70545/
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