[Recalled] Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. — A issue (bug) has been identified with the interface and image
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. |
|---|---|
| Brand / manufacturer | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2253-2021 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 June 2021 |
| EAN / barcode | 00863520000307 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.