Simpleware ScanIP medical software — Class II medical device recall Z-2254-2021
Terminated recall by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE, reported 2021-08-18, distributed nationwide. A issue (bug) has been identified with the interface and image software which could result in anatomical orien
| Recall number | Z-2254-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE, Exeter, N/A, United Kingdom |
| Recall initiated | 2021-06-04 |
| Classified | 2021-08-12 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2022-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, FR, GB |
| Quantity | 6 software |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 00863520000338, 00863520000345, 00863520000352, 00863520000369, 00863520000376, 00863520000383 |
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
Machine access
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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.