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Terminated

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

FDA Recall Z-0270-05 · Posted 2004-12-02

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-10-06
Date Terminated2005-09-02
Product Quantity67

Reason for Recall

Software defect causes images to be rotated 180 degrees.

Firm Action

Firm sent a letter to consignees October 6, 2004 describing the observed conditions causing the flaw to manifest itself. A workaround solution is also described in the letter. A software correction is under development and will be installed by a TAMS representative in the future.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023511EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002-11-05K002531EXCELART 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 · 1996-06-14

Official Source

View FDA Recall →

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

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