Z-0143-2024Class II

Universal Viewer Workflow Manager, Image processing radiological system

Name: Z-0143-2024 Universal Viewer Workflow Manager, Image processing radiological system
Creator: GE Healthcare
Published: 2023-09-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2023-09-08 / Open, Classified / root cause: software

FDA source

GE Healthcare began a recall of Universal Viewer Workflow Manager, Image processing radiological system on 2023-09-08. FDA classified it as Class II and gives the reason as "When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM 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-0143-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-08
Posted: 2023-10-23
Recalling firm: GE Healthcare
Product: Universal Viewer Workflow Manager, Image processing radiological system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.
Quantity in commerce: 57 units
Distribution: Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.
Product codes and lots: UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0143-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0142-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0143-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23

Product code LLZ

K211312Class IIUniversal ViewerGE Healthcare / cleared 2021-05-21

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)