Z-0551-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2018
- Initiation Date
- November 5, 2018
- Termination Date
- June 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65
Product Description
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
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.
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.
Code Information
Serial Numbers 700004 through 700018. Serial Numbers 700019 through 700086 as of 1/15/19.