Ion Beam Applications S.A.: Medical Device Recall in 2017 - (Recall #: Z-1830-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Proteus 235, Proton Therapy System

Product Classification:

Class II

Date Initiated: March 21, 2017

Date Posted: April 26, 2017

Recall Number: Z-1830-2017

Event ID: 76804

Reason for Recall:

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

Status: Terminated

Product Quantity: 2 worldwide, 1 in U.S.

Code Information:

Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Distribution Pattern:

Distribution in US (to Louisiana), and France.

Voluntary or Mandated:

Voluntary: Firm initiated