Class II — C-RAD POSITIONING AB
| Recalling firm | C-RAD Positioning AB |
|---|---|
| Registered facility | C-RAD POSITIONING AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | PC Application Software c4D not changing Site upon synchronization during the Setup workflow step |
| Product | PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 |
| Quantity | 7 |
| Distribution | US Nationwide distribution in the states of IL, KY, MO and WA. |
| Initiated | 2020-08-06 |
| Classified | 2021-07-14 |
| Terminated | 2022-04-15 |
| Recall number | Z-2075-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C-RAD POSITIONING AB (Z-2075-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88084/
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