Class 2 Device Recall Captus 3000 Thyroid Uptake System

• Date Initiated by Firm: November 05, 2018
• Date Posted: December 04, 2018
• Recall Status: Terminated on June 30, 2020
• Recall Number: Z-0550-2019
• Recall Event ID: 81605
• Product Classification: Probe, uptake, nuclear - Product Code IZD
• Product: Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
• Code Information: Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.
• FEI Number: 3000123149
• Recalling Firm/ Manufacturer: Capintec Inc; 7 Vreeland Road; Florham Park NJ 07932
• Manufacturer Reason for Recall: There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground.
• FDA Determined Cause: Under Investigation by firm
• Action: Notification letters were sent to customers on 11/5/18. A Revised Product Alert - Corrective Action letter was sent to customers beginning 1/15/19 due to an expansion of the event.
• Quantity in Commerce: 385
• Distribution: Worldwide distribution - US nationwide distributed in the states of AR, AZ, CA, CO, CT, DC, FL, IA, IN, LA, MD, MI, MN, NC, NJ, OH, OK, PA, SC, SD, TX, VA, WI, WV, and countries of Argentina, Brazil, Canada, China, Cyprus, Greece, Hong Kong, India, Japan, South Korea, Vietnam.
• 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.