Z-0550-2019 Class II Terminated

Recalled by Capintec Inc — Florham Park, NJ

Recall Details

Product Type
Devices
Report Date
December 12, 2018
Initiation Date
November 5, 2018
Termination Date
June 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
385

Product Description

Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

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.

Distribution Pattern

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.

Code Information

Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.