FDA recall Z-2434-2021

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

Product

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

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.

Key facts

Status
Ongoing
Initiation date
2021-06-14
Report date
2021-09-15
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-2434-2021