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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity

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  Class 2 Device Recall GE Centricity see related information
Date Initiated by Firm October 15, 2021
Create Date December 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-0329-2022
Recall Event ID 88959
510(K)Number K131977  
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Centricity Universal Viewer Zero Footprint Client
Code Information Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 There is a potential to display incomplete patient imaging study.
FDA Determined
Cause 2		 Software design
Action The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system.
Quantity in Commerce 638 devices
Distribution Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE HEALTHCARE
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