Z-0195-2019Class II

Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher

Name: Z-0195-2019 Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher
Creator: GE Healthcare, LLC
Published: 2018-08-30
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-08-30 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher on 2018-08-30. FDA classified it as Class II and gives the reason as "Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0195-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-10-18
Terminated: 2022-08-31
Recalling firm: GE Healthcare
Product: Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present.
Root cause tag: design
FDA root cause: Component design/selection
Action: On August 30, 2018, GE Healthcare sent Urgent Medical Device Correction letters to customers with affected units. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. 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 in commerce: 1
Distribution: NY
Product codes and lots: SYSTEM ID: 315470CPUWPV UDI #: 8406821038 00DE #: 2090255-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-18

Product code LLZ

K150420Class IICentricity Universal ViewerGE Healthcare / cleared 2015-05-26

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)