FDA-Device2016-08-03Class II
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 mam
Ge Healthcare It
Hazard
A software defect was discovered that causes images to be out of context with clinical information.
Sold states
US Nationwide Distribution.
Affected count
13
Manufactured in
540 W Northwest Hwy, N/A, Barrington, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2300-2016Don't want to check this manually?
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