Capintec Inc: Medical Device Recall in 2018 - (Recall #: Z-0551-2019)

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 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138

Product Classification:

Class II

Date Initiated: November 5, 2018

Date Posted: December 12, 2018

Recall Number: Z-0551-2019

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: 65

Code Information:

Serial Numbers 700004 through 700018. Serial Numbers 700019 through 700086 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