PC Application Software c4D as part of the device Catalyst: SP-002… — Class II medical device recall Z-2075-2021
Terminated recall by C-RAD POSITIONING AB, reported 2021-07-21, distributed nationwide. PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
| Recall number | Z-2075-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C-RAD POSITIONING AB, Uppsala, Sweden |
| Recall initiated | 2020-08-06 |
| Classified | 2021-07-14 |
| Reported by FDA | 2021-07-21 |
| Terminated | 2022-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 7 |
| Reason classes | software |
| Model numbers | PA-003 |
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 for recall
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2075-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.