FDA Device recall Z-2075-2021
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
- FDA Device
- Class II
- terminated
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 by C Rad Positioning Ab, citing PC Application Software c4D not changing Site upon synchronization during the Setup workflow step.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2075-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-06 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | C Rad Positioning Ab |
| Distribution | US |
Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Reason
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Identifiers
| code_info | Catalyst: SP-002, Software (part number): PA-003 version 6.1.1 and 6.1.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2075-2021%22
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