Ion Beam Applications S.A. Recall 89731
Description: ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Ion Beam Applications S.A. Recall 89731 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0747-2022 |
| Event ID | 89731 |
| Event Description | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235 |
| Product Type | Devices |
| Distribution | IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands, |
| Quantity | 15 units US; 22 units OUS |
| Recall Reason | When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range |
| Device Classification | 20220316 |
| Device Code Info | PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109 (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK), SBF.117 (EU), SBF.128 (US). UDI: (01)05404013801138 |
| Center Classification Date | 20220310 |
| Recall Initiation Date | 20220215 |
| Recalling Firm | Ion Beam Applications S.A. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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