FDA Device recall Z-2097-2017
Proton therapy system -Proteus 235 aka Proteus Plus
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Proton therapy system -Proteus 235 aka Proteus Plus by Ion Beam Applications, citing A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2097-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-10 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL |
Product
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Identifiers
| code_info | Serial numbers: PAT.003, PAT.006 |
|---|
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-2097-2017%22
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