AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
This recall has been terminated (originally issued June 10, 2006).
- Recall Initiated
- April 28, 2006
- Posted
- June 10, 2006
- Terminated
- November 24, 2008
- Recall Number
- Z-1104-06
- Quantity
- 5
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
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.
Distribution
The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
Lot / Code Info
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].
Root Cause
Other
Action Taken
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.