Ion Beam Applications S.A. Recall 88196
Description: Proteus 235-Proton Therapy System
Ion Beam Applications S.A. Recall 88196 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2155-2021 |
| Event ID | 88196 |
| Event Description | Proteus 235-Proton Therapy System |
| Product Type | Devices |
| Distribution | FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands |
| Quantity | 5 US; 8 OUS |
| Recall Reason | if 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 Classification | 20210804 |
| Device Code Info | Serial 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 Date | 20210728 |
| Recall Initiation Date | 20210526 |
| Recalling Firm | Ion Beam Applications S.A. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |