CAPINTEC INC

CAPTUS 3000 · Gastroenterology and Urology

510(k): 0 Recall: 3 UDI: 0 MAUDE: 6 Class.: 0

Recalls (3)

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

2018-11-05

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.

Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.

2012-07-24

Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me

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.

2010-09-20

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.

MAUDE Adverse Events (6)

Malfunction

20181113

Malfunction

20181004

Injury

20131211

Malfunction

20131211

Malfunction

20120705

Malfunction