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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

Landauer: microSTARii Dosimetry Systems Recalled for Removal of Medical Use References

Agency Publication Date: March 21, 2024
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Summary

Landauer is recalling 975 microStar Reader units, including model numbers 10015-000, 10016-000, 10036-000, 10044-000, 10055-000, BC30058, and BC30059. The manufacturer is permanently discontinuing the microSTARii medical dosimetry system and must remove all references to medical applications from the product's user manuals and software. This action is necessary because the device is no longer intended for medical use and will be removed from customers who use them exclusively for medical purposes.

Risk

Using these dosimetry readers for medical applications after they have been discontinued for such use could lead to improper radiation measurements or clinical decisions based on obsolete software and manuals. While no specific injuries have been reported, the manufacturer is removing the devices from medical environments to prevent their use in healthcare settings where they are no longer supported or validated.

What You Should Do

  1. Identify your device by checking the model number on the unit; affected models include 10015-000, 10016-000, 10036-000, 10044-000, 10055-000, BC30058, and BC30059 (EMEA market models include 100, 101, 102, 110, and 201).
  2. Stop using the microStar reader for any medical applications, including use with nanoDot or other dosimeters in a clinical environment.
  3. Review the updated user manual and software provided by Landauer which removes all references to medical applications.
  4. If your facility uses the microStar reader exclusively for medical applications, prepare for the manufacturer to remove the reader from your site as part of this voluntary discontinuance.
  5. Contact Landauer directly to coordinate the removal of the device or to receive updated documentation if you use the device for non-medical purposes.
  6. Contact your healthcare provider or the manufacturer for further instructions regarding this discontinuance.
  7. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Removal of device and documentation updates

How to: Manufacturer will remove devices from medical-only customers and provide updated software/manuals to others.

Affected Products

Product: microStar Reader, Model 10015-000 (EMEA 100, 102, 110, 201)
Model / REF:
10015-000
100
102
110
201
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model 10016-000 (EMEA 101)
Model / REF:
10016-000
101
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model 10036-000
Model / REF:
10036-000
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model 10044-000
Model / REF:
10044-000
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model 10055-000
Model / REF:
10055-000
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model BC30058
Model / REF:
BC30058
Lot Numbers:
All Lot/Serial Numbers
Product: microStar Reader, Model BC30059
Model / REF:
BC30059
Lot Numbers:
All Lot/Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94043
Status: Resolved
Manufacturer: Landauer
Sold By: Authorized medical device distributors; Landauer
Manufactured In: United States
Units Affected: 975 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.

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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.