Z-1542-2008

Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with...

Name: Z-1542-2008 Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with...
Creator: Hitachi Medical Systems America Inc
Published: 2008-02-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2008-02-11 / Terminated / root cause: design

FDA source

Hitachi Medical Systems America Inc began a recall of Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive... on 2008-02-11. The reason FDA records is "The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1542-2008
Status: Terminated
Initiated: 2008-02-11
Posted: 2008-08-23
Terminated: 2010-09-24
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm issue a DEVICE CORRECTION letter to their customers on 2/11/2008. The letter informs the customers of the Emergency Rundown Switch Unit (ERDU) defect and provides a warning which lists instructions for the safe use of the ERDU Unit. The letter informs the customer(s) that their local Hitachi Field Service Engineer (FSE) will be scheduling a visit to test the ERDU in order to verify its state of operation. The letter also states that This test requires specific tools in order to verify the operation without actually quenching the magnet and that Hitachi will begin the test ING in March, 2008 and will continue the program until all installed ERDU units are verified. Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
Quantity in commerce: 235 units
Distribution: The recalled device units were distributed to customers located in the following states nationwide: CA, OH, IL, NJ, NY, FL, TX, NE, AR, MD, OR, MN, NV, MS, OK, IN, TN, MO, SC, VA, HI, LA, NC, NM, WY, WA, AL, PA, UT, WA, and KY
Product codes and lots: Units were distributed nationwide from 05/23/2001 to 12/07/2007. If you have questions concerning this action, contact Douglas J. Thistlethwaite at (800) 800-3106 x3720.

Product code LNH

K002420Class IIHitachi AltaireHitachi Medical Systems America, Inc. / cleared 2000-10-17

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)