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Terminated

MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.

FDA Recall Z-0029-2007 · Posted 2006-10-12

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-08-16
Date Terminated2012-04-13
Product Quantity348 units

Reason for Recall

Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.

Firm Action

On 8/16/2006, Hitachi issued two (2) Device Correction letters. The first letter was addressed to the five (5) customers whose system units are currently ''de-installed''. This letter informs the customers of the problem and asks that the customer(s) please contact the firm''s Customer Service Center on their toll-free tel. # 1-800-800-4925, in order to schedule a device correction should the customer ever re-activate/install their system(s). The second letter, issued to the customers with activated MRP-7000 and/or AIRIS MRI systems, informs the customers of the problem, and states that a HMSA Service (person) will be contacting the customer in order to schedule a device correction which should address the problem.

Root Cause

Other

Distribution Pattern

Nationwide and Puerto Rico.

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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