Date Initiated by Firm |
February 25, 2008 |
Date Posted |
July 24, 2008 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number |
Z-1571-2008 |
Recall Event ID |
47253 |
510(K)Number |
K0601608
|
Product Classification |
Radiation Therapy System - 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/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087-2371
|
For Additional Information Contact |
330-425-1313 Ext. 3720
|
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 |
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
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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.
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