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Terminated

Hitachi AIRIS II MRI System

FDA Recall Z-1115-06 · Posted 2006-06-14

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-04-25
Date Terminated2008-10-29
Product Quantity248

Reason for Recall

Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.

Firm Action

The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006.

Root Cause

Other

Distribution Pattern

The devices were distributed to consignees located throughout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001334HITACHI AIRIS IIHitachi Medical Systems America, Inc. · 2000-07-06K974212AIRIS IIHitachi Medical Systems America, Inc. · 1998-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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