Hitachi Echelon MRI System/Oasis MRI recall: Software Issue
Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging…
Why was Hitachi Echelon MRI System/Oasis MRI recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
- Product
- Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging…
- Recalling firm
- Hitachi Medical Systems America Inc
- Quantity
- 165 units
- 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.
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)