Recall Z-2470-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditio
| Date | Jun 27, 2018 |
| Status | Terminated |
| Reason | Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient. |
| Root cause | Device Design |
| Action | Recall was initiated on 6/27/18. Firm plans to provide the Urgent Medical Device Correction notifications to IBA site managers present on customer sites. The site managers will deliver the notification to customers by hand or email. The recall letter alerts users to the potential issue and instructs users to verify that apertures and accessories are fully inserted with both sides in the guide. The firm plans to deploy a solution on or before May 31, 2019, that will prevent occurrences of the issue. |
| Quantity | 14 |
| Distribution | US Nationwide Distribution in the states of FL, VA, PA, OK, NJ, WA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A., Apr 11, 2006 |