Ion Beam Applications S.A.: 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

Is my product affected?

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

• UPC 05404013801138

Check against the official notice below — it lists the full affected range.

What happened

Ion Beam Applications S.A. has recalled four units of the Proteus235 Proton Therapy System used to deliver proton beam treatment for localized tumors and other conditions. The recalled units have serial numbers PAT108, PAT112, and SAT116 in the United States, and PAT107 in Europe. The systems are affected by a defect in which the first layer of Uniform Scanning treatment fields may be irradiated with incorrect Scanning Magnet setpoints, potentially resulting in treatment fields that are smaller than expected and irradiated areas that receive more radiation dose than prescribed.

The affected devices were distributed nationwide in Illinois, Virginia, and Washington, as well as in Germany. The recalled units are identified by UDI-DI (01)05404013801138. The source document does not specify a remedy or required action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

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. Quantity: 4 units Lot/code info: UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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