Z-1115-06

Hitachi AIRIS II MRI System

Name: Z-1115-06 Hitachi AIRIS II MRI System
Creator: Hitachi Medical Systems America Inc
Published: 2006-04-25
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-04-25 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi AIRIS II MRI System on 2006-04-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1115-06
Status: Terminated
Initiated: 2006-04-25
Posted: 2006-06-14
Terminated: 2008-10-29
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi AIRIS II MRI System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 248
Distribution: The devices were distributed to consignees located throughout the United States.
Product codes and lots: Serial Numbers: C322- to C546; and C746 to C772

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)