Magnetic Resonance Imaging Device
FDA Recall Z-0910-06 · Posted 2006-05-31
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-02-21
Date Terminated2012-02-16
Product Quantity1129
Reason for Recall
The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
Firm Action
The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K032232AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICEHitachi Medical Systems America, Inc. · 2003-09-29K022390HITACHI ALTAIREHitachi Medical Systems America, Inc. · 2002-10-11K002420HITACHI ALTAIREHitachi Medical Systems America, Inc. · 2000-10-17K974212AIRIS IIHitachi Medical Systems America, Inc. · 1998-02-09
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.