Device product
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Z-0551-2019
Product summary
- Firm
- Capintec Inc
- Event
- Event 81605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65
- Official record key
device-enforcement:Z-0551-2019
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.