Capintec Captus 3000 Thyroid Uptake System Nuclear recall: Software Issue
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid…
Why was Capintec Captus 3000 Thyroid Uptake System Nuclear recalled?
Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 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, is excluded. This system does not have the ability to perform thyroid uptake procedures.)
- Product
- Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid…
- Recalling firm
- Capintec Inc
- Quantity
- 256
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
- Recall date
- September 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)