Atlas FDA

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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