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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Oasis Magnetic Resonance Scanners Software

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  Class 2 Device Recall Hitachi Oasis Magnetic Resonance Scanners Software see related information
Date Initiated by Firm September 01, 2009
Date Posted May 04, 2010
Recall Status1 Terminated 3 on February 24, 2012
Recall Number Z-1534-2010
Recall Event ID 54264
510(K)Number K072279  
Product Classification system, nuclear magnetic resonance imaging - Product Code IWE
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.
Code Information Model #'s: M001 - M043
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087
For Additional Information Contact
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		 The device has a software error that could potentially lead to a misdiagnosis.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Sites have already been corrected. Software updated from V1.0C to V2.0B
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IWE and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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