Capintec Inc: Medical Device Recall in 2018 - (Recall #: Z-0550-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 5, 2018

Date Posted: December 12, 2018

Recall Number: Z-0550-2019

Event ID: 81605

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.

Status: Terminated

Product Quantity: 385

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated