Capintec Captus 4000e Thyroid Uptake System Recall for Collimator Defect
Capintec is recalling Captus 4000e Thyroid Uptake Systems because insufficiently tapped screw holes may allow the collimator assembly to fall and contact patients or operators.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the collimator assembly may fall and contact a patient or operator, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Capintec Inc is recalling the Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152. The recall involves 48 units, with an additional 481 units added to the recall on March 26, 2020. These devices are intended to be used by trained nuclear medicine technologists or physicians to perform thyroid uptake procedures.
The recall was initiated because it is possible that the collimators have screw hole locations that were insufficiently tapped. This defect creates a potential for the collimator assembly to fall and come into contact with a patient or operator.
The affected devices were distributed worldwide, including in the United States, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. Users should check their serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
- Manufacturer
- Capintec Inc
Distribution
Distributed nationwide across the United States.
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