FDAClass IIDecember 12, 2018

Captus 3000 Thyroid Uptake System recall

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

Why was Captus 3000 Thyroid Uptake System recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.

Product
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Recalling firm
Capintec Inc
Quantity
385
Distribution
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.
Recall date
December 12, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls