EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.
This recall has been terminated (originally issued September 9, 2009).
- Recall Initiated
- May 12, 2008
- Posted
- September 9, 2009
- Terminated
- July 20, 2011
- Recall Number
- Z-2055-2009
- Quantity
- 6 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.
Distribution
The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
Lot / Code Info
The following Serial Numbers of this device were subject to recall/software correction: 17084306, 17084308, 19921303, 17268307, 17268309, and 18190406.
Root Cause
Software design
Action Taken
HMSA issued a 'DEVICE CORRECTION' notification to their customers on 5/12/2008. The notification describes the potential data transmission problem (potential to archive studies done on different patients into the same patient folder) and the conditions under which this problem can occur. The notification cautions the user/customer to verify all images stored on the PACS (Picture Archiving and Communications System) in order to ensure that they do not contain images from a different patient. The DEVICE CORRECTION letter also states that the firm will be installing updated software on all affected systems beginning in June, 2008, in order to address this issue. It also states that a Hitachi Service Rep. will be contacting each customer and making arrangements to set up a convenient time to come out and perform a software upgrade. Lastly, the letter provides a toll-free telephone # to the firm's 'Customer Service Center: 1-800-800-4925, which the customer can use to obtain additional information, if desired.