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Terminated

MRP-7000, AIRIS Magnetic Resonance Imaging Systems

FDA Recall Z-1105-06 · Posted 2006-06-10

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-03-17
Date Terminated2008-11-13
Product Quantity283

Reason for Recall

Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.

Firm Action

On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.

Root Cause

Other

Distribution Pattern

Nationwide-The devices were distributed to consignees located througout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945155AIRISHitachi Medical Systems America, Inc. · 1995-05-24K911667HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICEHitachi Medical Systems America, Inc. · 1991-05-30

Official Source

View FDA Recall →

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

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