Iba Dosimetry Gmbh: Medical Device Recall in 2014 - (Recall #: Z-0168-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 25, 2014

Date Posted: November 12, 2014

Recall Number: Z-0168-2015

Event ID: 69583

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.

Status: Terminated

Product Quantity: 124 units

Code Information:

N/A

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated