FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi AIRIS II MRI System
- Recall number
- Z-1115-06
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi AIRIS II MRI System
- Status
- Terminated
- Initiated
- 2006-04-25
- Posted
- 2006-06-14
- Terminated
- 2008-10-29
- Reason
- 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.
- 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
- 248
- Distribution
- The devices were distributed to consignees located throughout the United States.
- Lot, serial or model codes
- Serial Numbers: C322- to C546; and C746 to C772
- 510(k) numbers
- ["K001334","K974212"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28