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Lower risk Medical device recall · FDA · Published August 12, 2021

GE Healthcare Centricity Universal Viewer 7.1 Software Issue: Study Changes Not Saved

GE Healthcare recalls Centricity Universal Viewer 7.0 software versions due to study changes not saving to archives. Affected units may experience data loss if images are modified.

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

🇺🇸 FDA recall #Z-0012-2022Medical deviceGE Healthcare ›
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Contact the company

Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer

GE Healthcare is recalling Centricity Universal Viewer software versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5. This issue means study changes might not save to archives, risking data loss for medical imaging work. Read more at govinfonow.com/recall/61954-ge-healthcare-centricity-universal-viewer-7-1-software-issue-study.

Source Summary by GovInfoNow · govinfonow.com/recall/61954-ge-healthcare-centricity-universal-viewer-7-1-software-issue-study · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0012-2022

Cite this page

“GE Healthcare Centricity Universal Viewer 7.1 Software Issue: Study Changes Not Saved.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61954-ge-healthcare-centricity-universal-viewer-7-1-software-issue-study. Based on FDA recall #Z-0012-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2022%22&limit=1).

The FDA announced on 2021-08-12 that GE Healthcare LLC voluntarily recalled Centricity Universal Viewer 7.0, Model 5829628-0XX radiological image processing systems due to a software anomaly. The hazard involves study changes not propagating to the Centricity Enterprise Archive or another Vendor Neutral Archive.

How to tell if you have it

  • GE Healthcare Centricity Universal Viewer 7.0, Model 5829628-0XX
  • Centricity Universal Viewer Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5
  • UPC 00840682145794

The hazard

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since 2017-10-04. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (2026-02-27), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (2022-07-15), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (2022-06-24). Additional similar recalls include GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall: Patient Data Mismatch Risk (2026-07-31), GE Healthcare Centricity PACS Software Recall: Patient Data Mismatch Risk (2026-07-31), and GE Healthcare Centricity Universal Viewer Zero Footprint Client Recall: Patient Info Mismatch Risk (2026-01-16).

How to tell if you have this one

Check for software versions 7.0 SP0.0.4.5 or 7.0 SP0.0.5 on the Centricity Universal Viewer. The product was sold with GTIN 00840682145794.

  • Brand
    GE Healthcare
  • Product
    GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Install the latest software update from GE Healthcare to fix the study propagation issue.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: yesNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: yesARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: yesMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, Illinois, Maine, Mississippi, Nebraska, New Jersey, New York, Tennessee.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Aug 12, 202112. FDA classified it Class II: Oct 1, 202123. Published in FDA’s Enforcement Report: Oct 13, 202134. FDA terminated the recall: Aug 22, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

No, this recall is low risk. The issue only affects data storage, not patient safety.

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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-0012-2022 (August 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0012-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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