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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Event Detail

Event ID 64740
Product Type Devices
Status Ongoing
Recalling Firm Ge Healthcare It
City Barrington
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution: US including states of: AL, AZ, CT, FL, GA, IA, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, TX, VA, WI, WV + District of Columbia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Imagecast PACS versions prior to Class II In Imagecast PACS versions prior to, 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. 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. 43 units Z-0773-2014