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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 Falling Collimator Risk

Agency Publication Date: February 9, 2024
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Summary

Mirion Technologies (Capintec), Inc. is recalling 467 Captus 4000e Thyroid Uptake Systems due to potential spring arm failure. This defect can cause the heavy collimator component to fall suddenly to its lowest point, which could lead to physical injury for the patient or the medical professional operating the device. These systems are used in medical settings to perform thyroid uptake procedures and were distributed across the United States and several international locations.

Risk

The spring arm that supports the system's collimator can fail, causing the heavy component to drop without warning. This poses a direct impact and crushing risk to anyone positioned beneath or near the device during a medical procedure.

What You Should Do

  1. Check your device's model and serial number to see if it is included in this recall. Affected models include 5430-30151, 5430-30152, and 5430-30154.
  2. Locate the serial number on your system; affected units have serial numbers ranging from 940000 through 940535.
  3. Verify the Unique Device Identifier (UDI) codes on the product labeling, which are 0859942006096 or 0859942006102.
  4. Contact your healthcare provider or Mirion Technologies (Capintec), Inc. immediately for further instructions regarding the safety of your specific unit and to arrange for any necessary repairs or inspections.
  5. For additional questions or to report a problem, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

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

Affected Products

Product: Captus 4000e Thyroid Uptake Systems
Model / REF:
5430-30151
5430-30152
5430-30154
UPC Codes:
0859942006096
0859942006102
Lot Numbers:
Serial Numbers: 940000 through 940535

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93824
Status: Active
Manufacturer: Mirion Technologies (Capintec), Inc.
Sold By: Nuclear Medicine Departments; Medical Equipment Distributors
Manufactured In: United States
Units Affected: 467 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.