Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
This recall has been terminated (originally issued May 4, 2010).
- Recall Initiated
- September 1, 2009
- Posted
- May 4, 2010
- Terminated
- February 24, 2012
- Recall Number
- Z-1534-2010
- Quantity
- 43
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The device has a software error that could potentially lead to a misdiagnosis.
Distribution
Nationwide distribution: AZ, CA, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, MO, NC, NY, OH, OK, OR, PA, RI, SC, TX, VA, WA, WI, and WY.
Lot / Code Info
Model #'s: M001 - M043
Root Cause
Software design (manufacturing process)
Action Taken
Sites have already been corrected. Software updated from V1.0C to V2.0B
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