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.
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAIBA Proton Therapy System - PROTEUS 2352026-02-03
- FDAPluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-612024-09-23
- FDAIBA Proton Therapy System - 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 radiation2024-07-10
- FDAIBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions2024-07-08
- FDAIBA Proton Therapy System - 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.2024-05-10
- FDAIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.2024-03-04
- FDAION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA2023-09-29
- FDAION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA2023-09-29
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