FDAJune 4, 2021device
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
simpleware product group synopsys northern europesimplewaresimpleware product
UPCs
008635200003380086352000034500863520000369008635200003520086352000037600863520000383
Recall history
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