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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Healthcare: Centricity Universal Viewer Recalled for Potential Patient Information Mismatch

Agency Publication Date: October 23, 2023
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Summary

GE Healthcare is recalling approximately 142 units of Centricity Universal Viewer and Universal Viewer Workflow Manager software due to a critical patient identification error. When using these systems with a third-party reporting application to launch exams, the software may display medical information for a different patient than the one being viewed in the Workflow Manager. This software was distributed to healthcare facilities in 25 states and several international countries. GE Healthcare is initiating this voluntary recall to address the potential for clinical misinterpretation.

Risk

The software defect can cause a mismatch where a healthcare provider views one patient's images while the reporting tool displays a different patient's data. This error could lead to incorrect diagnoses or treatments being assigned to the wrong patient, posing a moderate risk of clinical harm.

What You Should Do

  1. Identify if your facility is using Centricity Universal Viewer Workflow Manager (Recall Z-0142-2024) with UDI/DI 00840682145794 or Universal Viewer Workflow Manager (Recall Z-0143-2024) with UDI/DI 00195278379610.
  2. Check your software version to see if it is 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, or 7.0 SP0.1.0, as all product IDs with these versions are impacted.
  3. Verify patient identification manually across all windows (Workflow Manager, Viewer, and third-party reporting tools) to ensure they match before proceeding with any medical analysis or reporting.
  4. Contact GE Healthcare immediately to confirm receipt of the notification letter and to receive further technical instructions or software updates.
  5. Healthcare providers with questions can contact GE Healthcare directly or reach out to the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Centricity Universal Viewer Workflow Manager, Image processing radiological system
Model / REF:
UDI/DI 00840682145794
Lot Numbers:
Software version 7.0 SP1.1
Software version 7.0 SP1
Software version 7.0 SP0.0.5
Software version 7.0 SP0.1.0
Product: Universal Viewer Workflow Manager, Image processing radiological system
Model / REF:
UDI/DI 00195278379610
Lot Numbers:
Software version 7.0 SP1.1
Software version 7.0 SP1
Software version 7.0 SP0.0.5
Software version 7.0 SP0.1.0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93053
Status: Active
Manufacturer: GE Healthcare
Sold By: GE Healthcare; Hospital supply channels
Manufactured In: United States
Units Affected: 2 products (85 units; 57 units)
Distributed To: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.