Z-0456-2014Class II

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

Name: Z-0456-2014 iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Creator: Iba Dosimetry Gmbh
Published: 2013-08-20
License: https://open.fda.gov/license/

IBA Dosimetry GmbH / initiated 2013-08-20 / Terminated / root cause: software

FDA source

Iba Dosimetry Gmbh began a recall of iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological on 2013-08-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0456-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-20
Posted: 2013-12-06
Terminated: 2014-02-24
Recalling firm: IBA Dosimetry GmbH
Product: iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. We deeply apologize for the inconvenience. We are working on a new software version with corrected functionality. This should become available during next fall and we will ship it to you as soon as it is released, together with the installation and verification instructions. Should you have questions or require additional information, please contact the Customer Service Team at: Service Department IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck, Germany Tel.:+49 9128 607 38 Fax: + 49 9128 607 26 Email: [email protected] .
Quantity in commerce: 33 units
Distribution: Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
Product codes and lots: SW Version 3.0. Catalong Number CS10-100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0456-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code IYE

K072374Class IICompassScanditronix Wellhofer GmbH / cleared 2007-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)