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U.S. Department of Health and Human Services

Class 3 Device Recall Diagnostic Ultrasound Unit

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 Class 3 Recall
Diagnostic Ultrasound Unit
see related information
Date Posted July 24, 2008
Recall Status1 Open
Recall Number Z-1571-2008
Recall Event ID 47253
Premarket Notification
510(K) Number
Product Classification System, Radiation Therapy, Charged-Particle, Medical - Product Code LHN
Product EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.
Code Information Serial Numbers: 11743701 to 11743705 11837701 to 11837705 11906701 to 11906705 12006701 to 12006710 12124701 to 12124710 12315701 to 12315705 12427801 to 12427805
Recalling Firm/
Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371
Manufacturer Reason
for Recall
Miscalculation reading. A software error in the firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans.
FDA Determined
Cause 2
DESIGN: Software Design
Action A Device Correction Letter was issue by the firm on 02/25/2008. The letter asks the affected customers not to use the value of ICA/CCA on the Measurement Report for diagnosis, but instead to follow the Immediate countermeasure detailed in the 'Note in Use' document which accompanies the Device Correction letter. The customers are asked to follow the Immediate Countermeasure until they receive a Temporary Countermeasure to correct the ICA/CCA ratio calculation. The Temporary Countermeasure will include: 1) a Disk to import a new carotid measure package; 2) an Installation booklet detailing how to import the new carotid measurement package and optional customization tools; and 3) an Operator manual addendum Upon release of the countermeasure, the firm's Applications or Servcie personnel shall perform the corrective action as identified in the Service Pack (A) Installation Instructions. Finally, upon release of the next software revision, service personnel will replace the software at each customer location.
Quantity in Commerce 20 units
Distribution Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
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.