Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- January 27, 2004
- Posted
- July 20, 2004
- Terminated
- July 13, 2005
- Recall Number
- Z-0546-04
- Quantity
- 24
- Firm Location
- Tustin, CA
Reason for Recall
Software anomally causes image slices to be in incorrect order.
Distribution
NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
Lot / Code Info
Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with softare V4.04*R251 to V4.10*R271.
Root Cause
Other
Action Taken
Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
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