Hitachi AIRIS Elite Magnetic Resonance Imaging Device
FDA Recall Z-0890-05 · Posted 2005-06-14
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2005-06-30
Date Terminated2010-09-14
Product Quantity35 devices
Reason for Recall
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Firm Action
The recalling firm is sending recall letters to all consignees.
Root Cause
Other
Distribution Pattern
The product was distributed throughout the United States and to one consignee located in both Wales and London.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.