Centricity recallZ-1333-2022 · GE Healthcare, LLC · initiated Jun 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1333-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2022
- Posted by the FDA
- Jul 5, 2022
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 1,934 units
- Product code
- LLZ
- FDA submissions
- K131977
- Distribution
- Worldwide distribution.
Product description
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 (models, lots, serial numbers)
UDI 00840682102988, Versions 6.0 SP6 through SP11.4
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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