Hitachi Medical Systems America Inc 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Model #'s: M001 - M043
Products Sold
Model #'s: M001 - M043
Hitachi Medical Systems America Inc is recalling Hitachi Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system produces t due to The device has a software error that could potentially lead to a misdiagnosis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device has a software error that could potentially lead to a misdiagnosis.
Recommended Action
Per FDA guidance
Sites have already been corrected. Software updated from V1.0C to V2.0B
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026