Ion Beam Applications S.A. recalls Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localize…

Recall date

January 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1477-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.