# FDA recall Z-2254-2021

> **Simpleware Product Group, SYNOPSYS NORTHERN EUROPE** · Class II · device recall initiated 2021-06-04.

## Product

Simpleware ScanIP medical software.  For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.

## Reason for recall

A issue (bug) has been identified with the  interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in  operator misunderstanding and errors during resampling or re-alignment of image data

## Distribution

US: Nationwide Distribution in the states of  CA,  FL  and countries of : France, United Kingdom, Germany, Australia

## Key facts

- **Recall number:** Z-2254-2021
- **Recalling firm:** Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-04
- **Report date:** 2021-08-18
- **Termination date:** 2022-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Exeter, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2254-2021

## Citation

> AI Analytics. FDA recall Z-2254-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2254-2021. Source: US FDA. Licensed CC0.

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