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HITACHI MEDICAL SYSTEMS AMERICA INC

OASIS · General Hospital

510(k): 2 Recall: 7 UDI: 0 MAUDE: 1 Class.: 66

510(k) Clearances (2)

OASIS MRI SYSTEM

2010-03-16

Substantially Equivalent

OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120

2008-02-11

Substantially Equivalent

Recalls (7)

Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, a

2018-06-18

The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.

Hitachi Oasis MRI System - C-Spine Coil

2017-01-06

The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

Hitachi Oasis MRI System

2015-04-16

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces tr

2014-04-25

The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

2013-01-31

Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image, which is lost.

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.

2012-06-15

Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu

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

2009-09-01

The device has a software error that could potentially lead to a misdiagnosis.

MAUDE Adverse Events (1)

Untitled record

20141209

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

General Hospital

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital

Infusion Safety Management Software

General Hospital

Vascular Access Port Kit

General Hospital

Tubing, Fluid Delivery

General Hospital

Basin, Emesis

General Hospital

Oral Administration Set

General Hospital

Ear Irrigation Kit

General Hospital

Nursing Pad, Cohesive Gel

General Hospital

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

General Hospital

Delivery Room Apparel Kit

General Hospital

Support, Scrotal, Therapeutic

General Hospital

Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

General Hospital

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

General Hospital

Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

General Hospital

Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

General Hospital

Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

General Hospital

Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

General Hospital

Water, Vascular Access Flush

General Hospital

Buret Administration Intravenous Kit

General Hospital

Allergen And Vaccine Delivery Needles

General Hospital

Bed, Ac-Powered Adjustable Hospital

General Hospital

Mattress And Bed Deck Cover (Medical Purposes)

General Hospital

Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital