Capintec recalls specific models of thyroid uptake systems due to potential collimator assembly falling and contacting patients or operators during use.
It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.
Capintec is recalling certain models of the Captus 4000e Thyroid Uptake System because the collimators might have screw holes that are too small, increasing the risk of the assembly falling and hitting patients or operators. This could cause injury during medical procedures.
The collimators have screw hole locations that were insufficiently tapped, meaning they could become loose and fall during use. If the collimator assembly falls, it might contact patients or operators, potentially causing injury.
Trained nuclear medicine technologists and physicians who use these systems for thyroid uptake procedures are most at risk. The recall affects specific model numbers and serial numbers listed in the notice.
Check if your Captus 4000e Thyroid Uptake System has model numbers 5430-30151 or 5430-30152, or a serial number from the list provided in the recall notice.
Inspect the collimator assembly for loose screw holes that might cause it to fall during use.
Model numbers 5430-30151 and 5430-30152 are affected, along with specific serial numbers listed in the recall notice.
The recall notice does not specify a fix or remedy; users are advised to check the collimator assembly for loose screw holes.
Check if your system has model numbers 5430-30151 or 5430-30152, or a serial number from the list provided in the recall notice.
We’ve drafted a message you can send Capintec to request your refund or repair — edit it as you like.
Subject: Recall Z-1564-2020 — Capintec Capintec Hello, I own a Capintec that is covered by recall Z-1564-2020 from Capintec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.