FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
- Recall number
- Z-1005-04
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
- Status
- Terminated
- Initiated
- 2004-05-07
- Posted
- 2004-07-20
- Terminated
- 2008-11-01
- Reason
- Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.
- Root cause
- Other
- Action
- The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
- Quantity
- 3 units
- Distribution
- The devices were shipped to consignees in OH, PA, WI.
- Lot, serial or model codes
- Serial Numbers: SE15704205, SE16773210, and SE16935305.
- 510(k) numbers
- ["K013723"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28