Capintec Captus 3000 Thyroid Uptake System Software Error Recall
Capintec is recalling Captus 3000 Thyroid Uptake Systems with specific software revisions due to a potential error in the 'Measure Liquid and Subtract Residual' protocol.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving a functional defect without reported harm.
Plain-English summary
Capintec Inc is recalling 256 units of the Capintec Captus 3000 Thyroid Uptake System. This recall involves systems equipped with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26. The affected devices are nuclear uptake probes intended for use by trained Nuclear Medicine Technologists to perform thyroid uptake procedures.
The recall is due to a potential error that may occur when using the 'Measure Liquid and Subtract Residual' protocol, a feature added in Software Revision 1.22. The error specifically occurs if the user does not measure the residual dose immediately after measuring the liquid. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Affected units were distributed worldwide, including the United States and countries such as Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey. Users should contact Capintec Inc for instructions on how to address the software issue.
The recalled product
- Product
- Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
- Manufacturer
- Capintec Inc
- Hazard
- Affected units
- 256
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Catalog numbers for new systems: 5430-0076
- 5430-0077
- 5430-0103
- inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730
- 2011 and June 30
- 2012 with Revision 1.22
- 1.23
- 1.24
- 1.25
- or 1.26. (NOTE: Item number 5430-0075
- Captus 3000 well counter system
Distribution
Distributed nationwide across the United States.
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