AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
FDA Recall Z-1104-06 · Posted 2006-06-10
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-04-28
Date Terminated2008-11-24
Product Quantity5
Reason for Recall
Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
Firm Action
The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.
Root Cause
Other
Distribution Pattern
The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
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.