IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Reported: May 1, 2024 Initiated: March 4, 2024 #Z-1603-2024
Product Description
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Reason for Recall
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Details
- Recalling Firm
- Ion Beam Applications S.A.
- Units Affected
- 8 units
- Distribution
- US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
- Location
- Ottignies-Louvain-La-Neuve, N/A
Frequently Asked Questions
What product was recalled? ▼
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.. Recalled by Ion Beam Applications S.A.. Units affected: 8 units.
Why was this product recalled? ▼
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1603-2024.
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