Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-1477-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 26, 2018

Date Posted: May 2, 2018

Recall Number: Z-1477-2018

Event ID: 79605

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5

Code Information:

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated