Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- May 7, 2004
- Posted
- July 20, 2004
- Terminated
- November 1, 2008
- Recall Number
- Z-1005-04
- Quantity
- 3 units
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
The devices were shipped to consignees in OH, PA, WI.
Lot / Code Info
Serial Numbers: SE15704205, SE16773210, and SE16935305.
Root Cause
Other
Action Taken
The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
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