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Lower risk Medical device recall · FDA · Published September 8, 2023

GE Healthcare Universal Viewer Workflow Manager Recall: Patient Data Mismatch Risk

GE Healthcare recalls Universal Viewer Workflow Manager software versions that may display incorrect patient information when launching exams via third-party applications. Affected units include specific software versions and product IDs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0143-2024Medical deviceGE Healthcare ›
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Contact the company

Recalling firmGE Healthcare500 W Monroe St · Chicago, IL 60661-3671
✎ GovInfoNow plain-language explainer

GE Healthcare is recalling certain versions of their Universal Viewer Workflow Manager software. This could cause the system to show information for the wrong patient when exams are launched through third-party applications. This mismatch might lead to incorrect patient care. Read more at govinfonow.com/recall/57356-ge-healthcare-universal-viewer-workflow-manager-recall-patient-data-mismatch.

Source Summary by GovInfoNow · govinfonow.com/recall/57356-ge-healthcare-universal-viewer-workflow-manager-recall-patient-data-mismatch · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0143-2024

Cite this page

“GE Healthcare Universal Viewer Workflow Manager Recall: Patient Data Mismatch Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57356-ge-healthcare-universal-viewer-workflow-manager-recall-patient-data-mismatch. Based on FDA recall #Z-0143-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2024%22&limit=1).

GE Healthcare voluntarily recalled its Universal Viewer Workflow Manager and Image processing radiological system on Sept. 8, 2023, according to the FDA. The device may display information for a different patient than intended when using third-party reporting applications.

How to tell if you have it

  • Brand: GE Healthcare
  • Product: Universal Viewer Workflow Manager, Image processing radiological system
  • UDI/DI: 00195278379610
  • Software versions: 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0

The hazard

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.

Context

GovInfoNow's records show GE Healthcare has 12 other recalls on record since Jan. 25, 2018. Other recent recalls of similar products include GE Healthcare Centricity PACS Server V7 Recall (July 31, 2026), GE Healthcare Centricity Universal Viewer Zero Footprint Client Recall (Jan. 16, 2026), and GE Healthcare Centricity PACS-IW with Universal Viewer Security Recall (Feb. 19, 2025).

How to tell if you have this one

Check if your Universal Viewer Workflow Manager software is version 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, or 7.0 SP0.1.0. The product ID UDI/DI 00195278379610 is also affected.

  • Brand
    GE Healthcare
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-0142-2024Centricity Universal Viewer Workflow Manager, Image processing radiological system; UDI/DI 00840682145794, 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.85 units
Z-0143-2024Universal Viewer Workflow Manager, Image processing radiological system; 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.57 units
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Universal Viewer Workflow Manager software version to see if it matches the affected versions listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 25 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Sep 8, 202312. FDA classified it Class II: Oct 23, 202323. Published in FDA’s Enforcement Report: Nov 1, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0143-2024 (September 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0143-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA