Recall Z-0167-2011
Capintec Inc · initiated September 20, 2010
Product
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.
Codes / lots: Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010
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.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-0167-2011
- Initiated
- September 20, 2010
- Posted by FDA
- October 28, 2010
- Terminated
- July 5, 2012
- Product code
- KPT – Calibrator, Dose, Radionuclide
- Quantity
- 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.
- Recalling firm
- Capintec Inc, Pittsburgh, PA