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Recall Observatory FDA recall evidence

Device product

Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077

Z-0550-2019

November 05, 2018

Class II

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

    reason.no_named_rule · v1.0.0

    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.