Z-2097-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 10, 2017
- Termination Date
- February 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for Recall
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Distribution Pattern
FL
Code Information
Serial numbers: PAT.003, PAT.006