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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 PACS Recalled Due to Potential Image Storage Failure

Agency Publication Date: September 24, 2024
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Summary

GE HealthCare has issued a voluntary recall for 2,138 units of its Centricity PACS radiological imaging systems, including versions V2, V3, V4, V6, and V7. The recall was initiated after a software issue was discovered where the system may stop storing medical images once it reaches its maximum limit of unique image identifiers (known as Ckeys). This defect can lead to the acquisition of partial patient studies, meaning critical diagnostic images could be missing from a medical record. Consumers and medical facilities should contact GE HealthCare for assistance with this technical issue.

Risk

If the system fails to store images, medical professionals may receive only a partial study of a patient's imaging. This could lead to a delay in diagnosis, a misdiagnosis, or the need for a patient to undergo a repeat imaging procedure due to missing data.

What You Should Do

  1. Identify if your facility is using Centricity PACS versions V2, V3, V4, V6, or V7. For versions V4, V6, and V7, verify the UDI/DI numbers 00840682124430, 00840682104807, and 00840682145572 respectively.
  2. Check your specific system identifier against the extensive list of affected system IDs, which include codes such as CARTI02312611, 501268SSASW, and over 1,000 other specific site and system identifiers mentioned in the recall documentation.
  3. Contact your local GE HealthCare representative or the manufacturer directly at 1-888-463-6332 to discuss the software issue and ensure your system is operating correctly.
  4. Consult with your healthcare provider or IT department to determine if any image storage failures have occurred during clinical use.
  5. For additional questions or to report issues, contact the FDA Medical Device Recall hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and technical assistance.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential technical updates to the PACS software.

Affected Products

Product: GE Healthcare Centricity PACS V2
Model / REF:
V2
Lot Numbers:
See system ID list in code information section
Product: GE Healthcare Centricity PACS V3
Model / REF:
V3
Lot Numbers:
See system ID list in code information section
Product: GE Healthcare Centricity PACS V4
Model / REF:
V4
UDI/DI 00840682124430
Lot Numbers:
See system ID list in code information section
Product: GE Healthcare Centricity PACS V6
Model / REF:
V6
UDI/DI 00840682104807
Lot Numbers:
See system ID list in code information section
Product: GE Healthcare Centricity PACS V7
Model / REF:
V7
UDI/DI 00840682145572
Lot Numbers:
See system ID list in code information section

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95243
Status: Active
Manufacturer: GE Healthcare
Sold By: Direct sales to hospitals and healthcare facilities; GE HealthCare
Manufactured In: United States
Units Affected: 2138 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 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.