Ion Beam Applications S.A.: Medical Device Recall in 2022 - (Recall #: Z-1205-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 20, 2022

Date Posted: June 8, 2022

Recall Number: Z-1205-2022

Event ID: 90213

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

Status: Ongoing

Product Quantity: 4 units

Code Information:

UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated