Reported Dec 12, 2018 · Terminated
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Capintec Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Capintec Inc · 7 Vreeland Road · Florham Park, NJ · 07932
Is this the product you have?
Captus 700 Thyroid Uptake SystemModel # 5430-3137 and 5430-3138
- Lot codes and dates
- Serial Numbers 700004 through 700018. Serial Numbers 700019 through 700086 as of 1/15/19.
- Amount recalled
- 65
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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