FDA-Device2024-10-02Class II

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

GE Healthcare
Hazard

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.

Sold states
Worldwide distribution.
Affected count
2138 units
Manufactured in
500 W Monroe St, Chicago, IL, United States
Products
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3214-2024

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