Hitachi Medical Systems America Inc Hitachi AIRIS II MRI System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi AIRIS II MRI System
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Serial Numbers: C322- to C546, and C746 to C772
Products Sold
Serial Numbers: C322- to C546; and C746 to C772
Hitachi Medical Systems America Inc is recalling Hitachi AIRIS II MRI System due to Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or pos. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
Recommended Action
Per FDA guidance
The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006.
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 noticePage updated: Jan 10, 2026