medical Class II Updated 2019-07-10

GE Healthcare, LLC recalls Centricity PACS Foundation Centricity PACS software produ

Recalled Product

Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.

Hazard / Issue

There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9, CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5
View official government recall

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