Medium RiskFDA Device

Capintec Inc: There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.

Agency Publication Date: December 4, 2018

Affected Products

Product: Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.

Product: Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138

Serial Numbers 700004 through 700018. Serial Numbers 700019 through 700086 as of 1/15/19.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81605

Status: Resolved

Manufacturer: Capintec Inc

Manufactured In: United States

Units Affected: 2 products (385; 65)

Agency Last Updated: January 29, 2019

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 · 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.