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-1214-2015 · Posted 2015-02-26
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-02-18
Date Terminated2016-05-16
Product Quantity128 systems
Reason for Recall
Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
Firm Action
Consignees were notified of the issue via telephone and site visit by GE Healthcare IT Field Engineers.
Root Cause
Software design
Distribution Pattern
Distributed US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV, and the country of Bermuda.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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