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

Recall date

November 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0550-2019

FDA classification

Class II

Brand / firm

Capintec Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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