FDA Recall
Terminated
Proteus 235, Proton Therapy System
Recall: Z-1830-2017
·
Initiated March 21, 2017
Recall
- Recall Number
- Z-1830-2017
- Event Number
- 76804
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- March 21, 2017
- Terminated
- September 19, 2018
- Address
- Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
Description
Proteus 235, Proton Therapy System
Reason
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Action
A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.
Distribution
Distribution in US (to Louisiana), and France.
Quantity
2 worldwide, 1 in U.S.