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Recall Observatory FDA recall evidence

Device product

Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138

Z-0551-2019

November 05, 2018

Class II

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

    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.