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Ion Beam Applications S.A. Recall 88196

Description: Proteus 235-Proton Therapy System

Ion Beam Applications S.A. Recall 88196 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2155-2021
Event ID88196
Event DescriptionProteus 235-Proton Therapy System
Product TypeDevices
DistributionFL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Quantity5 US; 8 OUS
Recall Reasonif the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Device Classification20210804
Device Code InfoSerial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
Center Classification Date20210728
Recall Initiation Date20210526
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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