Class 2 Device Recall Capintec Captus 3000 Thyroid Uptake System

• Date Initiated by Firm: July 24, 2012
• Date Posted: September 05, 2012
• Recall Status: Terminated on December 10, 2013
• Recall Number: Z-2312-2012
• Recall Event ID: 62982
• Product Classification: Probe, uptake, nuclear - Product Code IZD
• 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.
• 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.)
• Recalling Firm/ Manufacturer: Capintec Inc; 620 Alpha Dr; Pittsburgh PA 15238
• For Additional Information Contact: 412-963-1988
• Manufacturer 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
• FDA Determined 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 contact Capintec Customer Support Representative if you have any questions or concerns regarding this notification, or if you do not receive your replacement software. Capintec Customer Support can be reached by phone at 1-800-631-3826 or by email at getinfo@capintec.com or by visiting our website at www.capintec.com.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.