Company: GE Healthcare It
Date of Enforcement Report: 2/5/2014
Class lI:
PRODUCT
Imagecast PACS 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 and interpretations. Mammongraphic 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-0773-2014
REASON
In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was not accounted for. These versions of Imagecast PACS look for values to be present in the following tags to calculate a measurement from pixels to millimeters (mm): (0020,0030) Pixel Spacing and, (0018,1164) Imager Pixel Spacing. _x000D_ _x000D_ Because the estimated magnification factor is not used, distance measurements may not be calculated accurately if both the Pixel Spacing and Imager Pixel Spacing tags are not supplied.
RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 3/42011. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide and Internationally
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