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U.S. Department of Health and Human Services

Class 2 Device Recall Echelon and Oasis

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 Class 2 Recall
Echelon and Oasis
see related information
Date Posted August 23, 2012
Recall Status1 Terminated on February 19, 2013
Recall Number Z-2254-2012
Recall Event ID 62870
Premarket Notification
510(K) Numbers
K052172  K072279 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination.
Code Information Echelon, V001 through V061, inclusive. Oasis, M001 through M105, inclusive, M951
Recalling Firm/
Manufacturer
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg, Ohio 44087
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Douglas J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall
Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR takes an original volume dataset reconstructed in any plane view and creates a new image set from another view (i.e. axial to coronal, coronal to sagittal, etc.). The error causes the first image in the dataset to have a right/left reversed orientation. The software error can occur randomly when execu
FDA Determined
Cause 2
DESIGN: Software Design
Action Hitachi sent a Device Correction Notice letter dated June 18, 2012 to all affected customers. All letters are recorded by tracking number and date received by the consignee. The letter identified the affect product, problem and actions to be taken. All sites will be visited by Hitachi Service to install the software update to permanently resolve the issue at no cost to the facility. Software correction is targeted to start by September 1, 2012. For question contact the Manager of Regulatory Affairs at 800-800-3106 x3720.
Quantity in Commerce 165 units
Distribution US Nationwide Distribution - including the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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