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Terminated

Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.

FDA Recall Z-0167-2011 · Posted 2010-10-28

Recalling FirmCapintec Inc
Recall StatusTerminated
Product CodeKPT
Date Initiated2010-09-20
Date Terminated2012-07-05
Product Quantity9 units

Reason for Recall

The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.

Firm Action

Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer. Customers can contact Capintec concerning this recall at 201 825-9500.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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