C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Brand
C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden
Lot Codes / Batch Numbers
Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
Products Sold
Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0
C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden is recalling PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and due to PC Application Software c4D not changing Site upon synchronization during the Setup workflow step. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Recommended Action
Per FDA guidance
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..
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026