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Recall Observatory FDA recall evidence

Device product

IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

Z-2693-2024

July 10, 2024

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 95024
Status
Ongoing
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-2693-2024

Official wording

Reason: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Code information: UDI-DI: (01)05404013801138 Serial Numbers; PAT.108 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US).

Distribution pattern: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues