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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

Agfa Healthcare NV: XERO Viewer Software Recalled for Inaccurate Medical Imaging Reference Lines

Agency Publication Date: October 10, 2024
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Summary

Agfa Healthcare NV has recalled 801 units of its Enterprise Imaging XERO Viewer software, a tool used by medical professionals to view diagnostic imaging like CT scans. The software has a defect that causes reference lines to be placed incorrectly on images when the image data uses a specific format (non-square pixel spacing). This can lead to crosshairs and location markers being displayed in the wrong anatomical position on the screen. Because this tool is used for diagnosis and treatment planning, this misalignment could cause medical errors. Users should check their software version against the affected list and contact the manufacturer or their health system's IT department to ensure they receive the necessary software updates.

Risk

The software displays reference lines in the wrong location when images have non-square pixel spacing. This creates a risk of misdiagnosis or mistreatment because doctors may believe an anatomical feature is in a different location than it actually is during an exam or procedure.

What You Should Do

  1. Check your medical facility's imaging system to see if you are running Enterprise Imaging XERO Viewer software versions 8.0.0 through 8.4.1, or ICIS View versions 2014.1 or 2014.2.
  2. Verify if your software matches the UDI-DI 05400874000710 and look for specific version numbers including 8.1.2 or higher, 8.1.4 or higher, 8.2.0.100 or higher, 8.2.2.000 or higher, 8.3.2.000 or higher, or 8.4.0.000 or higher.
  3. Immediately notify your facility's IT or Biomedical Engineering department if you identify an affected version to determine if a software patch or update has been applied.
  4. Contact Agfa Healthcare NV directly at their Belgian headquarters or through your local representative to receive further instructions on identifying the defect and obtaining a software fix.
  5. Healthcare providers should review recent diagnoses made using the affected software if non-square pixel images were involved to ensure anatomical accuracy.
  6. For additional information or to report a related issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Software update and medical guidance

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

Affected Products

Product: Enterprise Imaging XERO Viewer
Model / REF:
8.0.0
8.0.1
8.1
8.1.1
8.1.2
8.1.3
8.1.4
8.2.0.000
8.2.1.000
8.2.2.000
8.3.0.000
8.3.1.000
8.3.2.000
8.4.0.000
8.4.1.000
8.1.5
8.2.0.100
ICIS View 2014.1
ICIS View 2014.2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95411
Status: Active
Manufacturer: Agfa Healthcare NV
Sold By: Agfa Healthcare NV; Specialty Medical Imaging Retailers; Hospital IT Procurement
Manufactured In: Belgium
Units Affected: 801 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.