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Terminated

Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.

FDA Recall Z-0937-04 · Posted 2004-07-20

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-05-06
Date Terminated2005-03-15
Product Quantity50

Reason for Recall

Software anomaly.

Firm Action

Firm will send letters followed by visits to install software repair.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3Toshiba America Mri, Inc. · 2000-10-26K993803EXCELART WITH PIANISSIMOToshiba America Mri, Inc. · 2000-02-06K990620EXCELARTToshiba 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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