The Recall Desk
HighFDA (Devices)·Z-3089-2024·Announced 2024-09-18

Proton Therapy System Software Allows Safety Verification Mechanisms to Be Disabled

The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a proton therapy system with a software defect allowing safety verification mechanisms to be deactivated during clinical use. Per the recall rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a severity score of 3.

Plain-English summary

The FDA has issued a Class II recall for the IBA Proton Therapy System, including PROTEUS 235 ProteusPLUS and ProteusONE models running affected software versions (PTS-8, PTS-10, PTS-11, and PTS-12). The recall affects 35 units distributed worldwide, including locations in multiple U.S. states and countries in Europe and Asia.

The software contains a defect that allows safety parameter verification mechanisms to be deactivated during clinical runtime. This could permit treatment parameters to proceed without the verification checks designed to ensure patient safety.

Affected facilities are located in the United States (Alaska, New Jersey, Pennsylvania, Virginia, Oklahoma, Florida, Kansas, Illinois, Louisiana, Michigan, Tennessee, and Texas) and internationally in Belgium, Czech Republic, Germany, Spain, France, India, Italy, Japan, Netherlands, Poland, Russia, Sweden, Singapore, and Taiwan.

The recalled product

Product
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Manufacturer
Ion Beam Applications S.A.
Category
Medical Device — Radiotherapy Equipment
Hazard
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE)
  • PAT.108 (US)
  • PAT.109 (US)
  • PAT.110 (US)
  • PAT.111 (FR)
  • PAT.112 (US)
  • PAT.113 (US)
  • PAT.114 (CZ)
  • PAT.115 (IT)
  • SAT.116 (US)
  • SAT.117 (PL)
  • SAT.118 (RU)
  • SAT.119 (US)
  • SAT.120 (DE)
  • SAT.122 (SE)
  • SAT.123 (US)
  • SAT.125 (IN)
  • SAT.126 (US)
  • SAT.127 (TW)
  • SAT.132 (NL)

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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