Reported Aug 18, 2021 · Terminated
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and…
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 medical 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
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 Simpleware ScanIP Medical 2 00863520000338Simpleware ScanIP O-2018.12: 00863520000338, Simpleware ScanIP Medical 3 00863520000345Simpleware ScanIP P-2019.09: 00863520000345, Simpleware ScanIP Medical 4 00863520000369Simpleware ScanIP Q-2020.03: 00863520000369, Simpleware ScanIP Medical 5 00863520000352Simpleware ScanIP Q-2020.06: 00863520000352, Simpleware ScanIP Medical 6 00863520000376Simpleware ScanIP R-2020.09: 00863520000376, Simpleware ScanIP Medical 7 00863520000383Simpleware ScanIP R-2021.03: 00863520000383 - Amount recalled
- 6 software's
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.
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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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