Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN
FDA device recall Z-0273-05 · posted 2004-12-02 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- Software defect causes patient identification number to be truncated.
- Action taken
- Firm issued a letter notifying users of systems that when transferring image data to a DICOM server for any patient born on January 1, to verify that the Patient ID is correct on the DICOM server after the transfer. Firm will modify the software by January 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 39 units
- Distribution
- Nationwide.
- Date initiated
- 2004-08-24
- Date posted
- 2004-12-02
- Date terminated
- 2005-09-02
- Location
- Tustin, CA
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