FDA Device recall Z-2672-2017
Proteus 235 and Proteus ONE proton therapy systems
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Proteus 235 and Proteus ONE proton therapy systems by Ion Beam Applications, citing recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2672-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-18 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, IL, LA, NJ, OK, PA, TN, TX, VA, WA |
Product
Proteus 235 and Proteus ONE proton therapy systems
Reason
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Identifiers
| code_info | Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115…Code/Serial Numbers: PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123 and SAT.126 |
|---|
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-2672-2017%22
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