Hitachi Medical Systems America Inc

All codes manufactured from 11/2/2009 to 3/4/2011, are subject to recall. Preirus (KE10584001-KE17585003)/Avius (KE11088001-KE11476102)

Radiology Devices

2

No

Nationwide distribution: USA including states of: CA, MD, KY, FL, MN, NJ, IA, OH, TX, IL, and IA.

Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). || The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.

Radiology Devices

2

No

Nationwide distribution, including Puerto Rico (PR).

Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.

The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005

Radiology Devices

2

No

Nationwide distribution, including Puerto Rico (PR).

Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.

Part numbers: MR-FC-2EO, MR-FC-3EO

Radiology Devices

2

No

Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.

Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO

Serial #'s S5001 - S5011

Radiology Devices

2

No

US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.

Hitachi Scenaria CT System Software || Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.