Capintec Inc: Medical Device Recall in 2012 - (Recall #: Z-2312-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 24, 2012

Date Posted: September 12, 2012

Recall Number: Z-2312-2012

Event ID: 62982

Reason for Recall:

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

Status: Terminated

Product Quantity: 256

Code Information:

Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)

Distribution Pattern:

Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated