GE Healthcare, LLC recalls Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, an…

Recall date

May 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1911-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.

Why it was recalled

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.

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 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.