Iba Dosimetry Gmbh: Medical Device Recall in 2015 - (Recall #: Z-1212-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 2, 2015

Date Posted: March 4, 2015

Recall Number: Z-1212-2015

Event ID: 70545

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.

Status: Terminated

Product Quantity: 124 units

Code Information:

Model : SW Version 3.1 Lot or Serial Number : n.a

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated