Z-0889-05

Hitachi AIRIS II Magnetic Resonance Imaging Device

Name: Z-0889-05 Hitachi AIRIS II Magnetic Resonance Imaging Device
Creator: Hitachi Medical Systems America Inc
Published: 2005-06-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2005-06-30 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi AIRIS II Magnetic Resonance Imaging Device on 2005-06-30. The reason FDA records is "Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0889-05
Status: Terminated
Initiated: 2005-06-30
Posted: 2005-06-14
Terminated: 2010-09-14
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi AIRIS II Magnetic Resonance Imaging Device
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm is sending recall letters to all consignees.
Quantity in commerce: 771 devices
Distribution: The product was distributed throughout the United States and to one consignee located in both Wales and London.
Product codes and lots: C002 thru C795, C907, and C910.

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)