Hitachi Medical Systems America Inc

Model #'s: M001 - M043

Radiology Devices

1

No

Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY.

Hitachi Oasis Magnetic Resonance Scanners Software V1.0C || The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The following Serial Numbers of this device were subject to recall/software correction: 17084306, 17084308, 19921303, 17268307, 17268309, and 18190406.

Radiology Devices

2

No

The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.

EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, || DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.

The following Serial Numbers for this device were subject to recall/software correction: 17094308, 17094309, 17150307, 17350302, 17094305, 17869402, 18435403, 18435404, 17492302, and 17204305.

Radiology Devices

2

No

The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.

EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

Serial numbers: CXR46202 through CXR46248 excluding CXR46207, CXR46208, CXR46215, and CXR46222.

Radiology Devices

2

No

Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI.

Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.

Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951

Radiology Devices

2

No

US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.

Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. || Product Usage: || The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.