Ion Beam Applications S.A.: Medical Device Recall in 2021 - (Recall #: Z-2155-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Proteus 235-Proton Therapy System

Product Classification:

Class II

Date Initiated: May 26, 2021

Date Posted: August 4, 2021

Recall Number: Z-2155-2021

Event ID: 88196

Reason for Recall:

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

Status: Ongoing

Product Quantity: 5 US; 8 OUS

Code Information:

Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).

Distribution Pattern:

FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated