Reported Dec 12, 2018 · Terminated
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
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 3000 Thyroid Uptake SystemModel # 5430-0076 and 5430-0077
- Lot codes and dates
- Serial Numbers 901100 through 901309. Serial Numbers 901310 through 901965 as of 1/15/19.
- Amount recalled
- 385
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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