Z-1566-2022Class II

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model...

Name: Z-1566-2022 (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model...
Creator: GE Healthcare, LLC
Published: 2022-07-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-07-15 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model... on 2022-07-15. FDA classified it as Class II and gives the reason as "Inaccurate Distance and Area measurements with use of Global Stack viewport". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1566-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-15
Posted: 2022-08-24
Recalling firm: GE Healthcare
Product: (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Inaccurate Distance and Area measurements with use of Global Stack viewport.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recalling firm issued letters dated 7/15/2022 via traceable means on 7/15/2022 to the following titles within their affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics. The letter explained the issue, the affected product details, and the actions to be taken by the customer/user, which included the following: The customer/user can continue to use the system in accordance with User Manuals and the following actions: It is recommended the customer/user does not rely on measurements displayed in the Global Stack viewport in the Viewer. Users can perform the measurement activity by (1) Using Overview or Series Viewport to perform the measurement; or (2) If using Global Stack viewport, manually calibrate the image to create a measurement calibration reference and then perform necessary measurements. The customer/user is to complete and return the attachment acknowledgement form to the link in the letter or through the QR code. The customer/user was requested to ensure all potential users in their facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected products and a representative will be in contact with the customer/user to arrange for the correction. After the software has been corrected, the customer/user is to destroy all previous versions of the locally stored application installation package(s) immediately.
Quantity in commerce: 1,690 devices
Distribution: Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Aruba, Australia, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: (1) Centricity Universal Viewer 6.0 - UDI 00840682103800; Software versions 6.0 SP9, 6.0 SP9.0.1 through 6.0 SP9.0.1.11, 6.0 SP9.0.2, and 6.0 SP10 through 6.0 SP10.4. (2) Centricity Universal Viewer 7.0 - UDI 00840682145794, 00840682145558; Software versions 7.0 through 7.0 SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610; Software versions 8.0, 8.0 SP0.1.0, and 8.0 SP0.1.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1566-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1566-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-24

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)