Recall Z-2254-2012— Hitachi Medical Systems America Inc

Name: FDA recall Z-2254-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2012-06-15, terminated 2013-02-19. It names 2 FDA 510(k) clearances: K072279, K052172. Product: 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.. Reason: 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.

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Terminated: 2013-02-19
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc.·cleared 2007-09-21
K052172 — HHF1 MAGNETIC RESONANCE IMAGING SYSTEMHitachi Medical Systems America, Inc.·cleared 2005-09-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.