Z-1104-06

AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems

Name: Z-1104-06 AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Creator: Hitachi Medical Systems America Inc
Published: 2006-04-28
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-04-28 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems on 2006-04-28. The reason FDA records is "Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis". 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-1104-06
Status: Terminated
Initiated: 2006-04-28
Posted: 2006-06-10
Terminated: 2008-11-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
Root cause tag: software
FDA root cause: Other
Action: The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006.
Quantity in commerce: 5
Distribution: The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
Product codes and lots: Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].

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)