FDA Device

AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems

Hazard

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.

What You Should Do

Remedy

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.

Products

AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Brand
Hitachi Medical Systems America Inc
UPC
Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].

Units Affected

5