Z-0550-2019 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
- 385
Product Description
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
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 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.