PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
- Recall Initiated
- August 6, 2020
- Terminated
- April 15, 2022
- Recall Number
- Z-2075-2021
- Quantity
- 7
Reason for Recall
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Distribution
US Nationwide distribution in the states of IL, KY, MO and WA.
Lot / Code Info
Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Root Cause
Component change control
Action Taken
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..