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Terminated

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.

FDA Recall Z-0731-2014 · Posted 2014-01-14

Recalling FirmGe Healthcare It
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-09-15
Date Terminated2016-06-10
Product Quantity748 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 ter

Firm Action

GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043415CENTRICITY PACS SYSTEMGe Medical Systems Information Technologies · 2005-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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