FDAFDA · Food and drugs·Recall number Z-1205-2022
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
Published June 8, 2022 · Recall initiated: April 20, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
- Lot
- UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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