| Class 2 Device Recall GE Centricity | |
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
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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
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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 |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LLZ
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