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Terminated

Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

FDA Recall Z-0546-04 · Posted 2004-07-20

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-01-27
Date Terminated2005-07-13
Product Quantity24

Reason for Recall

Software anomally causes image slices to be in incorrect order.

Firm Action

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.

Root Cause

Other

Distribution Pattern

NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990620EXCELARTToshiba America Mri, Inc. · 1999-05-14K961092VISARTToshiba America Medical Systems, In.C · 1996-06-14K933018MRT-50GPToshiba America Mri, Inc. · 1994-02-18

Official Source

View FDA Recall →

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

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