Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technolo

FDA device recall Z-2312-2012 · posted 2012-09-05 · Terminated

Recall details

Recalling firm

Capintec Inc

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

IZD

Quantity affected

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.

Date initiated

2012-07-24

Date posted

2012-09-05

Date terminated

2013-12-10

Location

Pittsburgh, PA