Reported Aug 18, 2021 · Terminated
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for…
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE · Bradninch Hall · Exeter, N/A · N/A
Is this the product you have?
- Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
- Lot codes and dates
- Affected version/UDI Simpleware ScanIP 7.0: Created before UDI-DI system (released December 2nd, 2014), Simpleware ScanIP 2016.09: 00863520000307, Simpleware ScanIP M-2017.06: 00863520000314, Simpleware ScanIP N-2018.03: 00863520000321
- Amount recalled
- 4 softwares
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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