Recall · FDA
Ion Beam Applications S.A.
Ion Beam Applications S.A. issued a Class II FDA recall (Z-2138-2018) initiated 2016-09-16: 12C
| Company | Ion Beam Applications S.A. |
|---|---|
| Recall number | Z-2138-2018 |
| Classification | Class II |
| Status | Terminated |
| Category | Devices |
| Initiated | 2016-09-16 |
| Product | 12C |
| 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. |
FAQ
What did Ion Beam Applications S.A. recall?
12C
Why was Ion Beam Applications S.A.'s product recalled?
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.