Home / Recalls / Iba Dosimetry Gmbh / Z-0456-2014

Z-0456-2014 Class II Terminated

Recalled by Iba Dosimetry Gmbh — Schwarzenbruck

Recall Details

Product Type
Devices
Report Date
December 18, 2013
Initiation Date
August 20, 2013
Termination Date
February 24, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 units

Product Description

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

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.

Distribution Pattern

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.

Code Information

SW Version 3.0. Catalong Number CS10-100

Other recalls by Iba Dosimetry Gmbh

  • Z-1703-2025 Class II — myQA iON; Article Number: MQ10-000; (April 1, 2025)
  • Z-2220-2017 Class II — Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-00 (April 26, 2017)
  • Z-0683-2016 Class II — IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 (December 10, 2015)
  • Z-1212-2015 Class II — COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, rad (February 2, 2015)
  • Z-0168-2015 Class II — COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear acc (September 25, 2014)