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

Recall Insight

This FDA Devices action (record #Z-0456-2014) was formally reported on December 18, 2013, with the manufacturer initiating the action on August 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Iba Dosimetry Gmbh is listed as the recalling firm, operating out of Schwarzenbruck. Federal records indicate 33 units units are affected.

The documented reason for this recall is: 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 gene… Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.