| Class 2 Device Recall GE Centricity PACS | |
Date Initiated by Firm | June 11, 2013 |
Date Posted | October 30, 2013 |
Recall Status1 |
Terminated 3 on June 10, 2016 |
Recall Number | Z-0116-2014 |
Recall Event ID |
65471 |
510(K)Number | K043415 |
Product Classification |
Radiological Image Processing System - Product Code LLZ
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Product | 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. |
Code Information |
GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1 |
Recalling Firm/ Manufacturer |
GE Healthcare It 540 W Northwest Hwy Barrington IL 60010-3051
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For Additional Information Contact | Ms. Jeme Wallace 847-277-4468 |
Manufacturer Reason for Recall | GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows:
1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation.
2) Interrupted workflow could break the |
FDA Determined Cause 2 | Software design |
Action | URGENT MEDICAL DEVICE CORRECTION letters dated June 11, 2013 was mailed to all customers alerting them to these potential safety issues. The software was modified to correct these defects and a GE Healthcare service representative will contact each customer to make arrangements for installation of the new software version at no charge to the customer.
Customers with concerns or questions about the market action can contact their local GE Healtchcare IT service representative or GE Healthcare's Remote Online Center - Customer Care Center at 1-800-437-1171. |
Quantity in Commerce | 623 units |
Distribution | Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV) and the countries of the UK, Taiwan, Switerzland, Sweden, Spain, Singapore, Saudi Arabia, Netherlands, Malaysia, Korea, Japan, Italy, Israel, India, Hong Kong, Germany, France, Denmark, China, Canada, Bermuda, Beligum and Australia. |
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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