Hitachi Medical Systems America Inc AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
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].
Products Sold
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].
Hitachi Medical Systems America Inc is recalling AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems due to Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the pote. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, IN, NE, OH, TX
Page updated: Jan 10, 2026