FDA Device Recall Z-0029-2007: Hitachi Medical Systems America Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0029-2007.

Recall Res Number

Z-0029-2007

Recalling Firm / Manufacturer

Hitachi Medical Systems America Inc

FEI Number

1528028

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-08-16

Date Posted

2006-10-12

Date Terminated

2012-04-13

Product Code

LNH

Event Number

36224

Product Quantity

348 units

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

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.

Action Details 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.

Distribution Pattern Nationwide and Puerto Rico.

Code Information / Serial Numbers AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.

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Medical Device Recall: Z-0029-2007

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer