FDAFDA · Food and drugs·Recall number Z-1830-2017
Proteus 235, Proton Therapy System
Published April 26, 2017 · Recall initiated: March 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Distribution in US (to Louisiana), and France.
- Lot
- Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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