Recall Z-2054-2009 ยท ITX Transducer, Ultrasonic, Diagnostic
Hitachi Medical Systems America Inc
EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
| Date | Sep 9, 2009 (initiated May 12, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 affe |
| Quantity | 10 units |
| Distribution | The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp., Feb 6, 2002 |