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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
Recall Number Z-0731-2014
Classification Class II
Code Info GE Centricity Software versions 3.X and higher and 4.X and higher
Product Distributed Qty 748 units
Reason For Recall There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once terminated, the transfer service skips the image being sent, and continues to send the image in the exam.

Event Detail

Event Id 64724
Product Type Devices
Status Ongoing
Recalling Firm Ge Healthcare It
City Barrington
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.