Ion Beam Applications S.A.: Medical Device Recall in 2014 - (Recall #: Z-1492-2014)

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:

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

Product Classification:

Class II

Date Initiated: December 4, 2013

Date Posted: April 30, 2014

Recall Number: Z-1492-2014

Event ID: 67678

Reason for Recall:

Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

Status: Terminated

Product Quantity: 4

Code Information:

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.

Distribution Pattern:

US Distribution including the states of OK, IL, NJ, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated