Hitachi Airis II

• • Terminated Z-1616-2010 FDA Unclassified (pre-2012) ·initiated 19 Apr 2010 ·on shared 510(k) K001334

  Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.

• • Terminated Z-1115-06 FDA Unclassified (pre-2012) ·initiated 25 Apr 2006

  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.

• • Terminated Z-0889-05 FDA Unclassified (pre-2012) ·initiated 30 Jun 2005

  Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001334 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hitachi Medical Systems America, Inc. →