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Terminated

Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE

FDA Recall Z-1045-04 · Posted 2004-07-20

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-06-07
Date Terminated2005-01-04
Product Quantity58

Reason for Recall

Wrong positioning may cause patient burns.

Firm Action

An advisory letter will issue to all users May 26, 2004, with updated positioning information, and an employee will visit to make sure the letter was received and understood.

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. · 2000-10-26K990620EXCELARTToshiba 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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