Ge Healthcare It recalls Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management sy…

Recall date

February 18, 2013

Source

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

Recall number

Z-2300-2016

FDA classification

Class II

Brand / firm

Ge Healthcare It

Sold / distributed

US Nationwide Distribution.

Why it was recalled

A software defect was discovered that causes images to be out of context with clinical information.

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

What was recalled

Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.