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Terminated

Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

FDA Recall Z-0281-06 · Posted 2005-12-14

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-10-12
Date Terminated2007-07-12
Product Quantity65

Reason for Recall

To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.

Firm Action

Toshiba America Medical Systems, Inc., (TAMS) customer service engineers will hand deliver The Advisory Letter and monitor the system during their monthly preventive maintenance.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032490TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2Toshiba America Medical Systems, In.C · 2003-08-21

Official Source

View FDA Recall →

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

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