Z-1105-06

MRP-7000, AIRIS Magnetic Resonance Imaging Systems

Name: Z-1105-06 MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Creator: Hitachi Medical Systems America Inc
Published: 2006-03-17
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-03-17 / Terminated / root cause: software

FDA source

Hitachi Medical Systems America Inc began a recall of MRP-7000, AIRIS Magnetic Resonance Imaging Systems on 2006-03-17. The reason FDA records is "Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a...". 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-1105-06
Status: Terminated
Initiated: 2006-03-17
Posted: 2006-06-10
Terminated: 2008-11-13
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
Root cause tag: software
FDA root cause: Other
Action: On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.
Quantity in commerce: 283
Distribution: Nationwide-The devices were distributed to consignees located througout the United States.
Product codes and lots: Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039

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)