Recall Z-2075-2021 ยท IYE Accelerator, Linear, Medical
C-RAD POSITIONING AB
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
| Date | Aug 6, 2020 |
| Status | Terminated |
| Reason | PC Application Software c4D not changing Site upon synchronization during the Setup workflow step |
| Root cause | Component change control |
| Action | On August 11, 2020, an e-mail letter containing PA-003-200806-001-01, c4D not changing Site upon synchronization during the Setup workflow step (attached) has been sent personally to our contact persons at the affected sites. In a second step C-RAD upgraded the software at all affected sites to bring back the system to the originally intended state.. |
| Quantity | 7 |
| Distribution | US Nationwide distribution in the states of IL, KY, MO and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113276 | CATALYST C-Rad Positioning AB, Feb 27, 2012 |