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
Check against the official notice below — it lists the full affected range.
Ion Beam Applications S.A. is recalling ProteusPLUS and ProteusONE proton therapy systems used to treat patients with localized tumors and other conditions. The systems have a safety defect: when an operator resumes treatment after pausing the proton beam, the system does not verify that the beam range remains at the prescribed setting. If an operator manually changed the beam range during a pause, the system may deliver a portion of the treatment beam with an incorrect range, potentially exposing patients to improper radiation delivery.
A total of 15 units were distributed in the United States across Illinois, Kansas, Louisiana, Florida, Michigan, Oklahoma, Pennsylvania, New Jersey, Tennessee, Texas, Virginia, and Washington. An additional 22 units were distributed internationally across Belgium, England, Germany, France, the Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, and the Netherlands. The recall notice does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 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 Lot/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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.