Z-0846-05

Altaire, Magnetic Resonance Imaging Device

Name: Z-0846-05 Altaire, Magnetic Resonance Imaging Device
Creator: Hitachi Medical Systems America Inc
Published: 2004-11-18
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2004-11-18 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Altaire, Magnetic Resonance Imaging Device on 2004-11-18. The reason FDA records is "The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0846-05
Status: Terminated
Initiated: 2004-11-18
Posted: 2005-05-17
Terminated: 2008-01-04
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Altaire, Magnetic Resonance Imaging Device.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.
FDA root cause: Other
Action: The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.
Quantity in commerce: 189 devices
Distribution: Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Product codes and lots: Serial numbers: L001 to L191.

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)