FDA Recall
Terminated
Proteus ONE and Proteus Plus
Recall: Z-2139-2018
·
Initiated September 16, 2016
Recall
- Recall Number
- Z-2139-2018
- Event Number
- 80221
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Finished device change control
- Initiated
- September 16, 2016
- Terminated
- February 8, 2019
- Address
- Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
Description
Proteus ONE and Proteus Plus
Reason
IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.
Action
IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.
Distribution
Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.