Z-0168-2015Class II

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

Name: Z-0168-2015 COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Creator: Iba Dosimetry Gmbh
Published: 2014-09-25
License: https://open.fda.gov/license/

IBA Dosimetry GmbH / initiated 2014-09-25 / Terminated / root cause: software

FDA source

Iba Dosimetry Gmbh began a recall of COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological on 2014-09-25. FDA classified it as Class II and gives the reason as "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". 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-0168-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-25
Posted: 2014-11-04
Terminated: 2015-01-26
Recalling firm: IBA Dosimetry GmbH
Product: COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.
Quantity in commerce: 124 units
Distribution: Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-04

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)