FDA recall Z-1205-2022

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

Product

Proteus235- Proton Therapy System: 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

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

Distribution

Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.

Key facts

Status
Ongoing
Initiation date
2022-04-20
Report date
2022-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louvain-la-neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2022