Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Simpleware ScanIP medical software. For transfer of imaging information from Recalled by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Due to A issue (bug) has been identified with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Simpleware Product Group, SYNOPSYS NORTHERN EUROPE directly.
Affected Products
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Quantity: 6 software's
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report