Z-0374-2019Class II

Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images...

Name: Z-0374-2019 Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images...
Creator: GE Healthcare, LLC
Published: 2018-10-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-10-11 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging... on 2018-10-11. FDA classified it as Class II and gives the reason as "Synchronization failure". 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-0374-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-11
Posted: 2018-11-02
Terminated: 2023-03-20
Recalling firm: GE Healthcare
Product: Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Synchronization failure
Root cause tag: software
FDA root cause: Software design
Action: On October 12, 2018 GE Healthcare send recall notification to all their consignees with the following instructions; If you do not use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, your system is not affected by the safety issue. If you do use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, please contact GE Healthcare service representative immediately. GE Healthcare will assist you in determining if your system is affected and, if necessary, will assist you with a solution to confirm that study updates are made in the Enterprise Archive, until GE Healthcare can install a correction on your system. GE Healthcare will provide a correction that will be installed by a GE service engineer. A GE Healthcare representative will contact you to arrange for the correction. This activity will be performed at no cost to you. Contact Information 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: 13
Distribution: CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey.
Product codes and lots: 102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0374-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0374-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02
Z-0375-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

Product code LLZ

K123174Class IICentricity Pacs-Iw with Universal ViewerGE Healthcare / cleared 2012-11-16

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)