Z-0731-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2014
- Initiation Date
- September 15, 2012
- Termination Date
- June 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 748 units
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.
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 ter
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.
Code Information
GE Centricity Software versions 3.X and higher and 4.X and higher