Recall Z-2434-2021 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
| Date | Sep 8, 2021 (initiated Jun 14, 2021) |
| Status | Open, Classified |
| Reason | Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment |
| Root cause | Device Design |
| Action | IBA issued an Urgent Medical Device Correction notification users of the device, starting June 14, 2021. Letter states reason for recall, health risk and action to take: IBA would like to remind Proteus235 users to verify with X-ray images or other means, after the display of the popup message, that the patient positions (represented by the couch position, mainly the 3 translations and 3 rotations parameters) recorded in the OIS are correct Labelling change IBA will update the user manuals to: - Describe under which conditions the popup message appears and the subsequent risks, especially that |
| Quantity | 27 worldwide, 11 in U.S. |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A., Jul 28, 2006 |