EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the phy

FDA device recall Z-1571-2008 · posted 2008-07-24 · Terminated

Recall details

Recalling firm

Hitachi Medical Systems America Inc

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.

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.

Root cause

Software design

Status

Terminated

Product code

LHN

Quantity affected

20 units

Distribution

Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.

Date initiated

2008-02-25

Date posted

2008-07-24

Date terminated

2012-02-24

Location

Twinsburg, OH