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U.S. Department of Health and Human Services

Class 2 Device Recall CXR4 Computed Tomography XRay System

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  Class 2 Device Recall CXR4 Computed Tomography XRay System see related information
Date Initiated by Firm April 14, 2009
Date Posted July 07, 2009
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-1651-2009
Recall Event ID 52430
510(K)Number K040902  
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
Code Information The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
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		 Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect.
FDA Determined
Cause 2		 Software design
Action HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired.
Quantity in Commerce 47 units
Distribution Nationwide distribution, including Puerto Rico (PR).
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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