Recall Z-1571-2008 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Hitachi Medical Systems America Inc
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.
| Date | Jul 24, 2008 (initiated Feb 25, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 20 units |
| Distribution | Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.