Recall Z-2312-2012— Capintec Inc
Class II · Terminated
Class II FDA medical device recall by Capintec Inc, initiated 2012-07-24, terminated 2013-12-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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 me.
- Recalling firm
- Capintec Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-24
- Terminated
- 2013-12-10
- Firm location
- Pittsburgh, PA, United States
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.