Hitachi Altaire Magnetic Resonance Imaging System
FDA Recall Z-1103-06 · Posted 2006-06-10
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Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-01-27
Date Terminated2008-11-13
Product Quantity213 devices have been distributed and installed.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide-The device was distributed to consignees located throughout the United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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