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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

Mirion Technologies (Capintec), Inc.: Captus 4000e Thyroid Uptake Systems Recalled for Collimator Detachment Risk

Agency Publication Date: May 24, 2024
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Summary

Mirion Technologies (Capintec), Inc. is recalling approximately 3,825 units of its Captus 4000e Thyroid Uptake Systems across three different models. The recall was initiated because the collimator—a heavy component used for radiation shielding and focusing—can unexpectedly detach and fall. This issue has been reported in multiple complaints and could lead to physical injury or equipment damage. These medical devices are used in healthcare settings for thyroid uptakes, bioassays, and wipe tests, and were distributed nationwide in the U.S. and internationally.

Risk

The heavy collimator component may unexpectedly detach from the system, posing a risk of impact injuries to patients or healthcare staff during diagnostic procedures.

What You Should Do

  1. Identify if you have an affected Captus 4000e Thyroid Uptake System by checking the Model Number, Unique Device Identifier (UDI), and Serial Number (S/N) range on your device label.
  2. For Model 5430-30151 (Standard System), verify if the UDI is 859942006096 and the Serial Number is between 940001 and 941398.
  3. For Model 5430-30152 (System with Well), verify if the UDI is 0859942006102 and the Serial Number is between 940001 and 941398.
  4. For Model 5430-30154 (System with Well and 2-inch shielding), verify if the UDI is 0859942006423 and the Serial Number is between 940001 and 941398.
  5. Contact your healthcare facility's equipment manager or the manufacturer, Mirion Technologies (Capintec), Inc., to receive instructions regarding inspection or repair of the collimator attachment.
  6. Report any incidents of component detachment or related injuries to the FDA's MedWatch program.
  7. For further questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer-initiated corrective action

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

Affected Products

Product: Captus 4000e Thyroid Uptake System
Model / REF:
5430-30151
UPC Codes:
859942006096
Lot Numbers:
S/N range 940001 through 941398
Product: Captus 4000e Thyroid Uptake System with Well
Model / REF:
5430-30152
UPC Codes:
0859942006102
Lot Numbers:
S/N range 940001 through 941398
Product: Captus 4000e Thyroid Uptake System with Well and 2 inch shielding
Model / REF:
5430-30154
UPC Codes:
0859942006423
Lot Numbers:
S/N range 940001 through 941398

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94570
Status: Active
Manufacturer: Mirion Technologies (Capintec), Inc.
Sold By: Mirion Technologies (Capintec), Inc.
Manufactured In: United States
Units Affected: 3 products (1,275 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.