Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
This recall has been terminated (originally issued November 2, 2004).
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- September 16, 2004
- Posted
- November 2, 2004
- Terminated
- July 13, 2005
- Recall Number
- Z-0061-05
- Quantity
- 22
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
Distribution
PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.
Lot / Code Info
Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021, A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013, A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.
Root Cause
Other
Action Taken
Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.
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