Medical device recalls Moderate risk

GE Healthcare, LLC recalls Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

Recall date
August 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0195-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
NY

Why it was recalled

Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.

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