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.
This recall has been terminated (originally issued August 23, 2012).
- Recall Initiated
- June 15, 2012
- Posted
- August 23, 2012
- Terminated
- February 19, 2013
- Recall Number
- Z-2254-2012
- Quantity
- 165 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
Root Cause
Software design
Action Taken
Hitachi sent a Device Correction Notice letter dated June 18, 2012 to all affected customers. All letters are recorded by tracking number and date received by the consignee. The letter identified the affect product, problem and actions to be taken. All sites will be visited by Hitachi Service to install the software update to permanently resolve the issue at no cost to the facility. Software correction is targeted to start by September 1, 2012. For question contact the Manager of Regulatory Affairs at 800-800-3106 x3720