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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/Monitoring Devices

Landauer: microSTARii Readers Recalled Due to Dosimeter Measurement Inaccuracies

Agency Publication Date: December 22, 2023
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Summary

Landauer is recalling 584 units of the microSTARii reader, a medical dosimetry system used to measure radiation doses. The recall includes model numbers 18000-000, 18001-000, and 18007-000 across all serial numbers. These devices may provide inaccurate radiation measurements due to issues with the reader's LED beam profile or debris buildup caused by the mechanical movement of the drawer. If these inaccuracies go undetected, it could lead to incorrect radiation dose assessments for patients or medical staff.

Risk

The reader may miscalculate radiation doses because of optical interference or internal debris that changes how the device responds. This poses a risk of medical professionals relying on incorrect data for treatment planning or safety monitoring, which could result in inappropriate radiation exposure.

What You Should Do

  1. Identify if you have a Landauer microSTARii reader by checking for model numbers 18000-000, 18001-000, or 18007-000 on the device labeling.
  2. Be aware that this recall affects all serial numbers for the specified models.
  3. Regularly perform Quality Control (QC) checks using known radiation doses to identify if your specific reader is exhibiting response changes or inaccuracies.
  4. Contact Landauer directly to discuss technical support, potential calibration needs, or further instructions regarding the LED beam and drawer debris issues.
  5. Contact your healthcare provider or facility administrator if you suspect that previous dosimetry measurements may have been compromised by equipment inaccuracy.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer support and technical guidance

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

Affected Products

Product: Landauer microSTARii reader, Medical Dosimetry System
Model / REF:
18000-000
18001-000
18007-000
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93524
Status: Resolved
Manufacturer: Landauer
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 584 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.