HHF1 Magnetic Resonance Imaging System

• • Terminated Z-1559-2013 FDA Class II ·initiated 31 Jan 2013

  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.

• • Terminated Z-2254-2012 FDA Class II ·initiated 15 Jun 2012

  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

• • Terminated Z-0152-2007 FDA Unclassified (pre-2012) ·initiated 14 Aug 2006 ·on shared 510(k) K052172

  Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K052172 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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