Z-0329-2022Class II

GE Centricity Universal Viewer Zero Footprint Client

Name: Z-0329-2022 GE Centricity Universal Viewer Zero Footprint Client
Creator: GE Healthcare, LLC
Published: 2021-10-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-10-15 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Centricity Universal Viewer Zero Footprint Client on 2021-10-15. FDA classified it as Class II and gives the reason as "There is a potential to display incomplete patient imaging study". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0329-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-15
Posted: 2021-12-02
Recalling firm: GE Healthcare
Product: GE Centricity Universal Viewer Zero Footprint Client
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a potential to display incomplete patient imaging study.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system.
Quantity in commerce: 638 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0329-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0329-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-08	2021-12-02

Product code LLZ

K131977Class IICentricity Universal Viewer Zero Footprint ClientGE Healthcare / cleared 2013-09-17

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)