Z-0910-06

Magnetic Resonance Imaging Device

Name: Z-0910-06 Magnetic Resonance Imaging Device
Creator: Hitachi Medical Systems America Inc
Published: 2006-02-21
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-02-21 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of Magnetic Resonance Imaging Device on 2006-02-21. The reason FDA records is "The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures". 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-0910-06
Status: Terminated
Initiated: 2006-02-21
Posted: 2006-05-31
Terminated: 2012-02-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Magnetic Resonance Imaging Device
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
Root cause tag: software
FDA root cause: Other
Action: The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.
Quantity in commerce: 1129
Distribution: Nationwide
Product codes and lots: L001-L225 - Altaire C001-C693* - AIRIS II C701-C790 - AIRIS II Upgrades H001-H091 - AIRIS Elite H701-H748* - AIRIS Elite Upgrades *The firm informed CIN-DO in their status reports for May, 2006 and again in August, 2007, that duplication was found in the number of system units originally reported to CIN-DO in early 2006. Ten (10) of the AIRIS II System units had been previously upgraded to AIRIS Elite units [System Unit Numbers: C012, C014, C032, C063, C111, C138, C263, C347, and C495] and are these numbers are reflected in the total # of AIRIS Elite System Unit Numbers listed above* **By the same token, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746, H747 & H748] were reportedly installed well after the corrective action was underway (7/28/06 to 11/24/2006) and were not-subject to corrective action. As a result, the total # of affected system units/customers has been revised to reflect the number reported by the firm [1129] beginning with their May, 2006 status report and continuing through to their final communication to CIN-DO dated 8/21/2007. - clp

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)