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Terminated

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.

FDA Recall Z-1534-2010 · Posted 2010-05-04

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeIWE
Date Initiated2009-09-01
Date Terminated2012-02-24
Product Quantity43

Reason for Recall

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

Firm Action

Sites have already been corrected. Software updated from V1.0C to V2.0B

Root Cause

Software design (manufacturing process)

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc. · 2007-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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