Iba Dosimetry Gmbh: Medical Device Recall in 2013 - (Recall #: Z-0456-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 20, 2013

Date Posted: December 18, 2013

Recall Number: Z-0456-2014

Event ID: 66808

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.

Status: Terminated

Product Quantity: 33 units

Code Information:

SW Version 3.0. Catalong Number CS10-100

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.

Voluntary or Mandated:

Voluntary: Firm initiated