Z-1103-06

Hitachi Altaire Magnetic Resonance Imaging System

Name: Z-1103-06 Hitachi Altaire Magnetic Resonance Imaging System
Creator: Hitachi Medical Systems America Inc
Published: 2006-01-27
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-01-27 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Altaire Magnetic Resonance Imaging System on 2006-01-27. The reason FDA records is "Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1103-06
Status: Terminated
Initiated: 2006-01-27
Posted: 2006-06-10
Terminated: 2008-11-13
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Altaire Magnetic Resonance Imaging System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.
FDA root cause: Other
Action: The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.
Quantity in commerce: 213 devices have been distributed and installed.
Distribution: Nationwide-The device was distributed to consignees located throughout the United States.
Product codes and lots: L001 thru L223.

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)