FDA Device recall Z-1477-2018
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other c…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other c… by Ion Beam Applications, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1477-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-26 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | IL, NJ, VA, WA |
Product
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.
Reason
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.
Identifiers
| code_info | 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1477-2018%22
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