Hitachi Medical Systems America Inc: Medical Device Recall in 2012 - (Recall #: Z-2254-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 15, 2012

Date Posted: August 29, 2012

Recall Number: Z-2254-2012

Event ID: 62870

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

Status: Terminated

Product Quantity: 165 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated