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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 65223
Product Type Devices
Status Ongoing
Recalling Firm AGFA Corp.
City Greenville
State SC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U Class II Customers could potentially experience intermittent, unintended and illogical movement when using the product. 104 Z-1487-2013
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