Company: Ge Healthcare It
Date of Enforcement Report 8/3/2016
Class lI:
PRODUCT
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.
Recall Number Z-2300-2016
REASON
A software defect was discovered that causes images to be out of context with clinical information.
RECALLING FIRM/MANUFACTURER
Ge Healthcare IT, Barrington, IL on 2/18/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13
DISTRIBUTION
Nationwide
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