Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
FDA Recall Z-0550-2019 · Posted 2018-12-04
Recalling FirmCapintec Inc
Recall StatusTerminated
Product CodeIZD
Date Initiated2018-11-05
Date Terminated2020-06-30
Product Quantity385
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.
Firm Action
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
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.