FDA-Device2018-12-12Class II
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Capintec Inc
Hazard
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.
Sold states
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.
Affected count
385
Manufactured in
7 Vreeland Road, N/A, Florham Park, NJ, United States
Products
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2019Don't want to check this manually?
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