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Terminated

Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,

FDA Recall Z-0061-05 · Posted 2004-11-02

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2004-09-16
Date Terminated2005-07-13
Product Quantity22

Reason for Recall

Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.

Firm Action

Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.

Root Cause

Other

Distribution Pattern

PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.

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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