FDA recall Z-2470-2018

Ion Beam Applications S.A. · Class II · device

Product

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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 for recall

Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.

Distribution

US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX.

Key facts

Status
Terminated
Initiation date
2018-06-27
Report date
2018-07-25
Termination date
2020-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louvain-la-neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2470-2018