FDA Recall
Terminated
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.
Recall: Z-1534-2010
·
Initiated September 1, 2009
Recall
- Recall Number
- Z-1534-2010
- Event Number
- 54264
- Firm
- Hitachi Medical Systems America Inc
- FEI Number
- 1528028
- Product Code
- IWE
- Status
- Terminated
- Root Cause
- Software design (manufacturing process)
- Initiated
- September 1, 2009
- Posted
- May 4, 2010
- Terminated
- February 24, 2012
- Address
- 1959 Summit Commerce Park, Twinsburg, OH, 44087
Description
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.
Reason
The device has a software error that could potentially lead to a misdiagnosis.
Action
Sites have already been corrected. Software updated from V1.0C to V2.0B
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.
Quantity
43