FDA Device recall Z-2684-2017
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliv…
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliv… by Ion Beam Applications, citing software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2684-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-13 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ion Beam Applications |
| Distribution | FL, IL, NJ, VA, WA |
Product
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason
Software issue
Identifiers
| code_info | Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003 |
|---|
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-2684-2017%22
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