FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
- Recall number
- Z-1333-2022
- Recalling firm
- GE Healthcare, LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2022-06-08
- Posted
- 2022-07-05
- Terminated
- not on file
- Reason
- Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
- Root cause
- 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
- 1,934 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI 00840682102988, Versions 6.0 SP6 through SP11.4
- 510(k) numbers
- ["K131977"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28