Company:Capintec Inc.
Date of Enforcement Report 9/12/12
Class ll:
PRODUCT
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. Recall Number Z-2312-2012
REASON
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 measuring and administering the dose.
RECALLING FIRM/MANUFACTURER
Capintec Inc ,Pittsburgh, PA on 7/24/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
256 units
DISTRIBUTION
Nationwide and Internationally
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