Z-1212-2015Class II

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

Name: Z-1212-2015 COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Creator: Iba Dosimetry Gmbh
Published: 2015-02-02
License: https://open.fda.gov/license/

IBA Dosimetry GmbH / initiated 2015-02-02 / Terminated / root cause: software

FDA source

Iba Dosimetry Gmbh began a recall of COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological on 2015-02-02. FDA classified it as Class II and gives the reason as "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...". 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-1212-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-02
Posted: 2015-02-26
Terminated: 2015-08-18
Recalling firm: IBA Dosimetry GmbH
Product: COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38
Quantity in commerce: 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.
Product codes and lots: Model : SW Version 3.1 Lot or Serial Number : n.a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1212-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1212-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-26

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)