Medical device recalls Moderate risk

GE Healthcare recalls GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

Recall date
August 5, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3214-2024
FDA classification
Class II
Brand / firm
GE Healthcare
Sold / distributed
Worldwide distribution.

Why it was recalled

GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.

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

What was recalled

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

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