Recall Z-2312-2012 ยท IZD Probe, Uptake, Nuclear
Capintec Inc
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.
| Date | Sep 5, 2012 (initiated Jul 24, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | The firm, CAPINTEC, INC., sent a "SOFTWARE ERROR ALERT" letter dated July 20, 2012 to all affected consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the four measuring steps outlined in the letter; DO NOT PRINT, EXIT THE THYROID UPTAKE MODULE, OR MEASURE ANOTHER PATIENT BEFORE YOU HAVE COMPLETED THESE FOUR MEASUREMENT STEPS; and follow the attached addendum for step-by step instructions. Capintec will send corrected software to all affected customers in approximately 2-3 weeks. The customers are instructed to co |
| Quantity | 256 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.