Company: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Date of Enforcement Report: 8/18/2021
Class II
PRODUCT
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Recall Number: Z-2253-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation on 6/4/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4
DISTRIBUTION
U.S. Nationwide and International