HITACHI

All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2

Radiology Devices

2

No

Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile

ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: || ¿ Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL || ¿ CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL || ¿ Marconi Models: Magellan || ¿ Hitachi Models: Sceptre and Sceptre XL

Serial Numbers: SE15704205, SE16773210, and SE16935305.

Radiology Devices

2

No

The devices were shipped to consignees in OH, PA, WI.

Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

Lot 14608300.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Canada, Germany and Spain.

Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.

Lot 14608300.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Canada, Germany and Spain.

Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.

All lots expiring on or before 11/05.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).