FDA Medical Device Recalls (openFDA)
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 number
- Z-1534-2010
- Recalling firm
- Hitachi Medical Systems America Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-09-01
- Posted
- 2010-05-04
- Terminated
- 2012-02-24
- Reason
- The device has a software error that could potentially lead to a misdiagnosis.
- Root cause
- Software design (manufacturing process)
- Action
- Sites have already been corrected. Software updated from V1.0C to V2.0B
- Quantity
- 43
- 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, serial or model codes
- Model #'s: M001 - M043
- 510(k) numbers
- ["K072279"]
- PMA numbers
- not on file
- Product code
- IWE
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28