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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 Device Recall CXR4 Computed Tomography Scanner see related information
Date Initiated by Firm November 05, 2008
Date Posted January 08, 2009
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-0608-2009
Recall Event ID 50167
510(K)Number K040902  
Product Classification Computed Tomography X-Ray System - 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 OH 44087
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		 Software design
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 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 = JAK and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
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