Z-0139-2024Class II

Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image...

Name: Z-0139-2024 Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image...
Creator: GE Healthcare
Published: 2023-09-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2023-09-14 / Open, Classified / root cause: software

FDA source

GE Healthcare began a recall of Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System on 2023-09-14. FDA classified it as Class II and gives the reason as "GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and...". 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-0139-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-14
Posted: 2023-10-20
Recalling firm: GE Healthcare
Product: Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Product code: LLZ System, Image Processing, Radiological
Reason for recall: GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative
Quantity in commerce: 17 units
Distribution: US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam
Product codes and lots: UDI/DI none, Installed Product ID #: 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785, 100759-1-Centricity Universal Viewer-02360986, 9842-4-Centricity Universal Viewer-19386293, 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 4705-1-Centricity Universal Viewer-02398923, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, HC3062-Centricity Universal Viewer-01462397, RU9761-UW PACS-IW UP TO 10K-02336112, ZA2533-Centricity Universal Viewer-00116577, YP3150-Centricity Universal Viewer-01639018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-20
Z-0139-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-20
Z-0140-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)