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U.S. Department of Health and Human Services

Class 2 Device Recall CXR4 Computed Tomography Scanner

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 Class 2 Recall
CXR4 Computed Tomography Scanner
see related information
Date Posted January 08, 2009
Recall Status1 Open
Recall Number Z-0608-2009
Recall Event ID 50167
Premarket Notification
510(K) Number
K040902 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications.
Code Information Serial numbers: CXR46202 through CXR46248 excluding CXR46207, CXR46208, CXR46215, and CXR46222.
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 Doug J. Thistlethwaite
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall
Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action On 11/5/2008 Hitachi Medical Systems sent recall notification letters entitled "URGENT - DEVICE RECALL CORRECTION" to its customers informing them of the problem with the software. They stated that a Hitachi service representative will contact each customer to schedule a software upgrade. For further information, please contact Hitachi Medical Systems America Inc. by telephone at 330-425-1313.
Quantity in Commerce 42
Distribution Nationwide Distribution --- including states of AZ, CA, DE, FL, ID, IL, IN, KS, KY, LA, MA, MO, NJ, NY, OH, OK, PA, PR, SC, TX, VA, and WI.
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 = JAK and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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