Z-0819-2020Class II

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources...

Name: Z-0819-2020 Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources...
Creator: GE Healthcare, LLC
Published: 2019-12-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-12-16 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources on 2019-12-16. FDA classified it as Class II and gives the reason as "Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0819-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Posted: 2020-01-17
Terminated: 2023-10-05
Recalling firm: GE Healthcare
Product: Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.
Quantity in commerce: 205
Distribution: Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Product codes and lots: Model 2088026-9XX Versions 6.0 SP10 or higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-17

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)