Florham Park, NJ, United States

Capintec Inc recalls

2 recalls recorded since 2018, most recently on 3 March 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls2

Ongoing (FDA)0

Terminated or completed2

Class I (FDA)0

Recall started: 3 March 2020
Terminated: 12 November 2021
Reason: It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.
Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. (list u
Initiated: Voluntary: Firm initiated
Recall number: Z-1564-2020

Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Proce

Recall started: 5 November 2018
Terminated: 30 June 2020
Reason: 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: 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.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0551-2019, Z-0550-2019

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.