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Terminated

Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

FDA Recall Z-0273-05 · Posted 2004-12-02

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-08-24
Date Terminated2005-09-02
Product Quantity39 units

Reason for Recall

Software defect causes patient identification number to be truncated.

Firm Action

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

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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