Z-2312-2012Class II

Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear...

Name: Z-2312-2012 Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear...
Creator: Capintec Inc
Published: 2012-07-24
License: https://open.fda.gov/license/

Mirion Technologies (Capintec), Inc. / initiated 2012-07-24 / Terminated / root cause: software

FDA source

Capintec Inc began a recall of Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake... on 2012-07-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2312-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-24
Posted: 2012-09-05
Terminated: 2013-12-10
Recalling firm: Mirion Technologies (Capintec), Inc.
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.
Product code: IZD Probe, Uptake, Nuclear
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: The firm, CAPINTEC, INC., sent a "SOFTWARE ERROR ALERT" letter dated July 20, 2012 to all affected consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the four measuring steps outlined in the letter; DO NOT PRINT, EXIT THE THYROID UPTAKE MODULE, OR MEASURE ANOTHER PATIENT BEFORE YOU HAVE COMPLETED THESE FOUR MEASUREMENT STEPS; and follow the attached addendum for step-by step instructions. Capintec will send corrected software to all affected customers in approximately 2-3 weeks. The customers are instructed to contact Capintec Customer Support Representative if you have any questions or concerns regarding this notification, or if you do not receive your replacement software. Capintec Customer Support can be reached by phone at 1-800-631-3826 or by email at [email protected] or by visiting our website at www.capintec.com.
Quantity in commerce: 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.
Product codes and lots: 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.)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2312-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2312-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-05

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)