PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 28, 2024 Initiated: July 10, 2024 #Z-2693-2024

Product Description

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

Reason for Recall

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

Details

Units Affected
19 units
Distribution
IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Location
Ottignies-Louvain-La-Neuve

Frequently Asked Questions

What product was recalled?
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. Recalled by Ion Beam Applications S.A.. Units affected: 19 units.
Why was this product recalled?
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2693-2024.