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.
Enforcement
- Recall Number
- Z-2254-2012
- Event ID
- 62870
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hitachi Medical Systems America Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2012
- Initiation Date
- June 15, 2012
- Classification Date
- August 22, 2012
- Termination Date
- February 19, 2013
- Address
- 1959 Summit Commerce Park, N/A, Twinsburg, OH, 44087, United States
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.
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
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
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.
165 units