Product Safety Recalls

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Ion Beam Applications S.A. Recall 90213

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

Ion Beam Applications S.A. Recall 90213 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1205-2022
Event ID90213
Event DescriptionProteus235- 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 TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Quantity4 units
Recall ReasonFirst 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
Device Classification20220608
Device Code InfoUDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
Center Classification Date20220527
Recall Initiation Date20220420
Recalling FirmIon Beam Applications S.A.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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