EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03

FDA device recall Z-2055-2009 · posted 2009-09-09 · Terminated

Recall details

Recalling firm

Hitachi Medical Systems America Inc

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.

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.

Root cause

Software design

Status

Terminated

Product code

ITX

Quantity affected

6 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.

Date initiated

2008-05-12

Date posted

2009-09-09

Date terminated

2011-07-20

Location

Twinsburg, OH

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