Z-2254-2012 Class II Terminated
FDA device recall Z-2254-2012 was initiated by Hitachi Medical Systems America Inc on June 15, 2012 and is designated Class II. 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 anot… The recall status is terminated (terminated February 19, 2013). Affected quantity: 165 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2012
- Initiation Date
- June 15, 2012
- Termination Date
- February 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 units
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
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.
Code Information
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951