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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 Software Recalled for Incorrect Report Displays

Agency Publication Date: October 9, 2024
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Summary

GE Healthcare is recalling approximately 1,500 units of the Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x software. The software contains a defect where it fails to show the most recent medical report by default when a patient study has multiple reports (such as preliminary, final, or addendum) stored in different series. This issue affects medical facilities worldwide using specific model and catalog numbers listed in the recall.

Risk

If the software does not display the most current medical report, healthcare providers may base clinical decisions on outdated or incomplete information. This could lead to a delay in diagnosis or the implementation of an incorrect treatment plan for the patient.

What You Should Do

  1. Identify if your facility is using Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x by checking the software version in the system settings.
  2. Cross-reference your system with the affected model and catalog numbers, which include 2089507-120, 2089507-129, 2089507-131, 2089507-135, 2089507-136, 2089507-140, 2089507-144, 2089507-145, 2089507-149, 2089507-153, 2089507-154, 2089507-155, 2089507-156, 2089507-157, K2037DAED, K2037DBED, K2037DED, K2037DJED, K2037DNED, K2042TTED, K2049DC, K2049DD, K2049DF, P2037DAED, P2037DBED, and P2037DED.
  3. Review the specific Installed Product ID Numbers and UDI/DI 840682102988 to confirm if your specific installation is part of the 1,500 units affected.
  4. Contact your healthcare IT department or GE Healthcare directly to receive the necessary software updates or patches to resolve the reporting display issue.
  5. Verify all patient reports manually by checking all available series within a study until the software update is successfully applied to ensure the latest information is being reviewed.
  6. Contact GE Healthcare for further technical instructions or to report any issues related to this software defect.
  7. For additional questions or to report safety concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer Notification and Software Correction

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

Affected Products

Product: GE Healthcare Centricity Universal Viewer Zero Footprint Client
Model / REF:
2089507-120
2089507-129
2089507-131
2089507-135
2089507-136
2089507-140
2089507-144
2089507-145
2089507-149
2089507-153
2089507-154
2089507-155
2089507-156
2089507-157
K2037DAED
K2037DBED
K2037DED
K2037DJED
K2037DNED
K2042TTED
K2049DC
K2049DD
K2049DF
P2037DAED
P2037DBED
P2037DED
2110344-022
2110344-023
2110344-031
2110344-034
2110344-035
2110344-036
2110344-037
Lot Numbers:
JP-570093-Centricity Universal Viewer Zero Footprint / ZFP-02368762
332068-Centricity Universal Viewer Zero Footprint / ZFP-19605736
UDI/DI 840682102988

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95307
Status: Active
Manufacturer: GE Healthcare
Sold By: GE Healthcare; Direct medical distribution
Manufactured In: United States
Units Affected: 1500 units
Distributed To: Nationwide

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 · 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.