The Recall Desk
HighFDA (Devices)·Z-2434-2021·Announced 2021-09-15

Proteus 235 Proton Therapy System May Display Misleading Popup Message

Ion Beam Applications is recalling certain Proteus 235 proton therapy systems because a misleading popup message may appear when the Oncology Information System disconnects, potentially causing treatment errors.

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 involving a risk-of-harm scenario in cancer therapy. The source text does not report any actual illnesses or injuries, making this a theoretical risk situation. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Ion Beam Applications S.A. is recalling the Proteus 235 proton therapy system. The device is designed to produce and deliver a proton beam for treating patients with localized tumors and other conditions susceptible to radiation treatment.

The recall involves a software issue in how the system displays information to operators. When the Oncology Information System appears to be disconnected, a popup message may mislead users about the system's status. This misleading message could result in mistreatment of patients.

A total of 27 Proteus 235 systems have been distributed worldwide, with 11 units in the United States. Affected U.S. locations include Florida, Oklahoma, Virginia, Illinois, New Jersey, Tennessee, Washington, Louisiana, Texas, and Michigan.

Patients and healthcare providers using the Proteus 235 should verify proper system connectivity and message clarity before conducting patient treatment. Contact the manufacturer for technical guidance on resolving this software issue.

The recalled product

Product
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Manufacturer
Ion Beam Applications S.A.
Category
Medical Device — Proton Therapy / Radiation Oncology
Hazard

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)

  • PAT.006 (US)
  • PAT.107 (EU)
  • PAT.108 (US)
  • PAT.110 (US)
  • PAT.112 (US)
  • PAT.113 (US)
  • PAT.114 (EU)
  • PAT.115 (EU)
  • SAT.116 (US)
  • SAT.118 (RU)
  • SAT.119 (US)
  • SAT.120 (EU)
  • SAT.122 (EU)
  • SAT.123 (US)
  • SAT.125 (IN)
  • SAT.126 (US)
  • SAT.132 (EU)
  • SBF.101 (EU)
  • SBF.103 (JP)
  • SBF.104 (JP)

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same manufacturer · Ion Beam Applications S.A.

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