FDA Recall
Terminated
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.
Recall: Z-2097-2017
·
Initiated April 10, 2017
Recall
- Recall Number
- Z-2097-2017
- Event Number
- 76977
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- April 10, 2017
- Posted
- May 3, 2017
- Terminated
- February 16, 2018
- Address
- Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
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
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.
Action
Target date for software update June 30, 2017. A Field Safety Notice was issued on 4/10/2017 describing the problem and reminding users to follow guidance in the user's manual.
Distribution
FL
Quantity
2