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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1205-2022 |
| Event ID | 90213 |
| Event 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 Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany. |
| Quantity | 4 units |
| Recall Reason | 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 |
| Device Classification | 20220608 |
| Device Code Info | UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU). |
| Center Classification Date | 20220527 |
| Recall Initiation Date | 20220420 |
| Recalling Firm | Ion Beam Applications S.A. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |