RecallRadar

FDA Device recall Z-1695-2017

Proteus 235

On 2017-04-05 the FDA classified a Class II recall of Proteus 235 by Ion Beam Applications, citing the Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1695-2017
ClassificationClass II
Statusterminated
Initiated2017-03-09
Published2017-04-05
Last updated2026-09-13 11:54 UTC
CompanyIon Beam Applications
DistributionFL, MA, TN, VA

Product

Proteus 235

Reason

The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

Identifiers

code_infoSerial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120

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-1695-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.