Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 910

FDA device recall Z-0167-2011 · posted 2010-10-28 · Terminated

Recall details

Recalling firm

Capintec Inc

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.

Action taken

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

Status

Terminated

Product code

KPT

Quantity affected

9 units

Distribution

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

Date initiated

2010-09-20

Date posted

2010-10-28

Date terminated

2012-07-05

Location

Pittsburgh, PA