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.
This recall has been terminated (originally issued July 24, 2008).
- Recall Initiated
- February 25, 2008
- Posted
- July 24, 2008
- Terminated
- February 24, 2012
- Recall Number
- Z-1571-2008
- Quantity
- 20 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
Lot / Code Info
Serial Numbers: 11743701 to 11743705 11837701 to 11837705 11906701 to 11906705 12006701 to 12006710 12124701 to 12124710 12315701 to 12315705 12427801 to 12427805
Root Cause
Software design
Action Taken
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.