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U.S. Department of Health and Human Services

Class 2 Device Recall Hitachi Scenaria CT System Software

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 Class 2 Recall
Hitachi Scenaria CT System Software
see related information
Date Posted July 19, 2012
Recall Status1 Terminated on February 19, 2013
Recall Number Z-2037-2012
Recall Event ID 62372
Premarket Notification
510(K) Number
K101888 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Code Information Serial #'s S5001 - S5011
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 in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
FDA Determined
Cause 2
DESIGN: Software Design
Action Hitachi sent a "Device Correction Notice" dated May 4, 2012 to their customers. The notice identified the affected product, problem and actions to be taken. Customers were instructed to "not use the Reconstruction Status" function to suspend active reconstructions until the software problem can be corrected. They also informed their customers that a representative will visit their facility to install the software update to permanently resolve the issue at no cost to the facility. For further information regarding this notice call 800-800-3106 x3720.
Quantity in Commerce Six (6) units
Distribution US Nationwide Distribution to the following states of: MD, MI, MX, ND, NY, OH and TX.
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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