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

FDA device recall Z-0550-2019 · posted 2018-12-04 · Terminated

Recall details

Recalling firm

Capintec Inc

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.

Action taken

Notification letters were sent to customers on 11/5/18. A Revised Product Alert - Corrective Action letter was sent to customers beginning 1/15/19 due to an expansion of the event.

Root cause

Under Investigation by firm

Status

Terminated

Product code

IZD

Quantity affected

385

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,

Date initiated

2018-11-05

Date posted

2018-12-04

Date terminated

2020-06-30

Location

Florham Park, NJ