Recall – Medical scanner system orientation displayed incorrectly

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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