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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity PACSIW with Universal Viewer

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  Class 2 Device Recall Centricity PACSIW with Universal Viewer see related information
Date Initiated by Firm October 28, 2022
Date Posted December 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0721-2023
Recall Event ID 91159
510(K)Number K123174  
Product Classification System, image processing, radiological - Product Code LLZ
Product Centricity PACS-IW with Universal Viewer version 5.0.

Used to display medical images (Including mammograms) and data from various imaging sources.
Code Information Installed Product ID: YP3150-Centricity Universal Viewer-01639018
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action GE Healthcare notified consignees on about 10/28/2022 via letter titled, "URGENT MEDICAL DEVICE CORRECTION - UPDATE." Consignees were instructed that the device can continued being used by following these instructions: 1) When a study is not present on the Study List, contact a GE Healthcare Service Representative for assistance in recovering the study. 2) In situations where study interpretation is time sensitive, interpret the study at the scanning unit or plan for an alternate means of reading studies for emergent cases. GE Healthcare will contact consignees to arrange for the correction. Consignees were also instructed to complete and return the acknowledgement form.
Quantity in Commerce 1 unit
Distribution Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
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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