Proteus 235 and Proteus ONE proton therapy systems
FDA Recall Z-2672-2017 · Posted None
Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-05-18
Date Terminated2019-02-08
Product Quantity18 worldwide and 10, in the U.S.
Reason for Recall
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Firm Action
An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed.
Root Cause
Employee error
Distribution Pattern
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.