Ion Beam Applications S.A.: Medical Device Recall in 2022 - (Recall #: Z-0747-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235

Product Classification:

Class II

Date Initiated: February 15, 2022

Date Posted: March 16, 2022

Recall Number: Z-0747-2022

Event ID: 89731

Reason for Recall:

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

Status: Ongoing

Product Quantity: 15 units US; 22 units OUS

Code Information:

PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138

Distribution Pattern:

IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,

Voluntary or Mandated:

Voluntary: Firm initiated