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Terminated

Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.

FDA Recall Z-0986-05 · Posted 2005-07-13

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-05-25
Date Terminated2012-04-05
Product Quantity102

Reason for Recall

Patient information A is displayed with images for patient B.

Firm Action

Firm will have technicians correct each unit by visit. Instructions to them have issued.

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 · 1996-06-14

Official Source

View FDA Recall →

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

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