Hitachi AIRIS II Magnetic Resonance Imaging Device
This recall has been terminated (originally issued June 14, 2005).
- Recall Initiated
- June 30, 2005
- Posted
- June 14, 2005
- Terminated
- September 14, 2010
- Recall Number
- Z-0889-05
- Quantity
- 771 devices
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Distribution
The product was distributed throughout the United States and to one consignee located in both Wales and London.
Lot / Code Info
C002 thru C795, C907, and C910.
Root Cause
Other
Action Taken
The recalling firm is sending recall letters to all consignees.
More recalls by Hitachi Medical Systems America Inc
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doc...
Mar 1, 2021
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be us...
Jan 31, 2020
Hitachi Scenaria Whole-body X-ray CT System
Oct 16, 2019