IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Recall
- Recall Number
- Z-1603-2024
- Event Number
- 94297
- Firm
- Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- March 4, 2024
- Posted
- April 19, 2024
Description
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
On 3/20/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers in person or via email by their customer representative. Customers were instructed to review the notice with their customer representative. Immediate actions taken: IBA carried out an analysis to determine if the impacted sites have some safety parameters checked by the BAPP in their clinical site configuration with values leading to violations. The result of this analysis showed that there are no sites with safety parameters checked by the BAPP out of tolerance. Intermediate action: While waiting for the solution to be deployed on your site, a regular automatic check that the safety parameters are within tolerances will be implemented. IBA will distribute an Internal User Notice to IBA operators of impacted sites to inform them that operators shall monitor alarms triggered by this check and directly inform you if a violation is detected. The intermediate action will be implemented for your site by April 30th, 2024, at the latest. The final solution will be implemented for your site by December 2025.By signing the response form, the customer representative confirms that this notice has been read, understood and communicated to the appropriate employees within the organization. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness of this notice and the resulting action for an appropriate period to ensure the effectiveness of the corrective action. The Food and Drug Administration has been informed of this Urgent Medical Device Correction. We apologize for any inconvenience that this may cause, and we would like to thank you for your cooperation. Your IBA representative can provide you with additional information and/or guidelines if necessary. Please contact Sonia Pinel, Head or Post Market Vigilance at +32 10 497 516 or [email protected] or the helpdesk +32 2 507 20 81 (available 24/7).
US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
8 units