Device product
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Z-0550-2019
Product summary
- Firm
- Capintec Inc
- Event
- Event 81605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 385
- Official record key
device-enforcement:Z-0550-2019
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 901100 through 901309. Serial Numbers 901310 through 901965 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.