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IBA Proton Therapy System - PROTEUS 235, PTS-10 versions… recallZ-1603-2024 · Ion Beam Applications S.A. · initiated Mar 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ion Beam Applications S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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).

Recall details

Recall number
Z-1603-2024
Status
Open, Classified
Initiated by the company
Mar 4, 2024
Posted by the FDA
Apr 19, 2024
Recalling firm
Ion Beam Applications S.A.
Quantity
8 units
Product code
LHN
FDA submissions
K163500
Distribution
US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

Product description

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

Code information (models, lots, serial numbers)

PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page