Aug

2021

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

DISTRIBUTION

U.S. Nationwide and International

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Recall – Medical scanner system orientation displayed incorrectly

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