CAPTUS 3000

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.)

Radiology Devices

1

No

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.

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.

Model Catalog: 5430-0106 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0118 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0087 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0077 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0076 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0118 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0107 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0106 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0087 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0077 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0076 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: Upgrade S/N CNV-366 to CNV-374)

Captus 3000 Thyroid Uptake System

Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010

Radiology Devices

2

No

Worldwide Distribution: USA in the states of NC and TN, and in the countries of Pakistan, Paraguay, Portugal, Saudi Arabia, and Spain.

Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA.