FDA Recall
Terminated
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Recall: Z-0938-2018
·
Initiated November 17, 2017
Recall
- Recall Number
- Z-0938-2018
- Event Number
- 79230
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 17, 2017
- Terminated
- June 14, 2021
- Address
- Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
Description
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Action
On November 17, 2017 an Urgent Field Safety Notice was issued to customers informing users that when creating or importing a treatment plan with multiple isocenters, the user has to enter Patient Positioning System positions manually.
Distribution
Nationally
Quantity
37