FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: Hitachi Altaire Magnetic Resonance Imaging Device.
- Recall number
- Z-0888-05
- Recalling firm
- Hitachi Medical Systems America Inc
- Product
- Hitachi Altaire Magnetic Resonance Imaging Device.
- Status
- Terminated
- Initiated
- 2005-06-30
- Posted
- 2005-06-14
- Terminated
- 2010-09-14
- Reason
- Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Root cause
- Other
- Action
- The recalling firm is sending recall letters to all consignees.
- Quantity
- 177 devices
- Distribution
- The product was distributed throughout the United States and to one consignee located in both Wales and London.
- Lot, serial or model codes
- L001 thru L182.
- 510(k) numbers
- ["K002420","K022390"]
- 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