IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

FDA device recall Z-1603-2024 · posted 2024-04-19 · Open, Classified

Recall details

Recalling firm

Ion Beam Applications S.A.

Reason for recall

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Action taken

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 Vigilance@iba-group.com or the helpdesk +32 2 507 20 81 (available 24/7).

Root cause

Device Design

Status

Open, Classified

Product code

LHN

Quantity affected

8 units

Distribution

US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

Date initiated

2024-03-04

Date posted

2024-04-19

Location

Ottignies-Louvain-La-Neuve, Belgium

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