Proteus 235-Proton Therapy System
- Recall Initiated
- May 26, 2021
- Recall Number
- Z-2155-2021
- Quantity
- 5 US; 8 OUS
Reason for Recall
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
Distribution
FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Lot / 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).
Root Cause
Labeling design
Action Taken
IBA issued Urgent Medical Device Correction notification starting on May 27, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users of the following warning present in the Clinical User Guide: As a Radiation Therapy Technologist (RTT), check before allowing the irradiation that the position of the selector switch of the external beam triggering interface is consistent with the prescription data in the patient file. There is a risk of mistreatment as the system does not automatically detect the gating prescription thereby always generating a continuous irradiation. Labelling change and training IBA will: - update the user manuals to recommend the customers to define a procedure for patients with gating prescribed in order to ensure that the system will be set correctly, - provide user training sessions about the preparation of a treatment with UBTI synchronization. The actions will be performed for your site by December 31, 2021. Your IBA representative is able to provide you with additional information and/or guidelines if necessary.