Proteus 235 Proton Therapy System for cancer treatment.

Recall Insight

This FDA Devices action (record #Z-0020-2015) was formally reported on November 5, 2014, with the manufacturer initiating the action on March 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Ion Beam Applications S.A. is listed as the recalling firm, operating out of Louvain La Neuve, N/A. Federal records indicate 8 units are affected.

The documented reason for this recall is: While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to acceler… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.. 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 12 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.