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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 June 08, 2022
Date Posted July 05, 2022
Recall Status1 Open3, Classified
Recall Number Z-1333-2022
Recall Event ID 90454
510(K)Number K131977  
Product Classification System, image processing, radiological - Product Code LLZ
Product GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
Code Information UDI 00840682102988, Versions 6.0 SP6 through SP11.4
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
FDA Determined
Cause 2		 Software design
Action GE notified their consignees by issuing an URGENT MEDICAL DEVICE CORRECTION notice on 08 June 2022. The letter explains the two safety issues and provides the following actions be taken: Issue #1: "You can continue to use your device in accordance with the User Manual and the actions below: Do not utilize any measurements when the 'Lossy' overlay is displayed in the lower left of the viewport and, when you hover over the word 'Lossy', it displays the tooltip box with the phrase 'Image scaled down from its original resolution'." Issue #2: "You can continue to use your device in accordance with the User Manuals and the actions below: Do not perform any measurement on non-squared pixel images. Always confirm critical diagnostic measurements by other means (i.e using a fiducial marker of known size)." GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. After the software has been corrected, be sure to destroy the installation media for affected software at your site. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 1,934 units
Distribution Worldwide distribution.
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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