# FDA recall Z-2075-2021

> **C-RAD POSITIONING AB** · Class II · device recall initiated 2020-08-06.

## 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

## Distribution

US Nationwide distribution in the states of IL, KY, MO and WA.

## Key facts

- **Recall number:** Z-2075-2021
- **Recalling firm:** C-RAD POSITIONING AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-06
- **Report date:** 2021-07-21
- **Termination date:** 2022-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uppsala, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2075-2021

## Citation

> AI Analytics. FDA recall Z-2075-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2075-2021. Source: US FDA. Licensed CC0.

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