Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Published May 2, 2018 · Recall initiated: January 26, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.
- Lot
- Affected version: PTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU); PAT.108, PAT.112, PAT.113, PAT.116 (US)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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