| Class 2 Device Recall GE Centricity PACS Workstation |  |
Date Initiated by Firm | November 15, 2012 |
Create Date | August 17, 2016 |
Recall Status1 |
Terminated 3 on December 13, 2017 |
Recall Number | Z-2579-2016 |
Recall Event ID |
64785 |
510(K)Number | K043415 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System
Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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. |
Code Information |
Centricity PACS versions 3.1.1.x through 3.2.1.x |
Recalling Firm/ Manufacturer |
GE Healthcare It 540 W Northwest Hwy Barrington IL 60010-3051
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For Additional Information Contact | Jeme Wallace 847-277-5000 |
Manufacturer Reason for Recall | While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager.
When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors. |
FDA Determined Cause 2 | Software design |
Action | GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196. |
Quantity in Commerce | 498 units |
Distribution | Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LLZ
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