Hitachi Altaire

• • Terminated Z-1542-2008 FDA Unclassified (pre-2012) ·initiated 11 Feb 2008

  The firm's Altaire MR Scanner's Emergency Rundown Switch Unit (ERDU), that is used to shut down the device in an emergency, was found to be defective. An ERDU failure could delay or prevent patient access leading to possible patient death or serious injury.

• • Terminated Z-1263-2007 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007

  Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.

• • Terminated Z-1104-06 FDA Unclassified (pre-2012) ·initiated 28 Apr 2006

  Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.

• • Terminated Z-0910-06 FDA Unclassified (pre-2012) ·initiated 21 Feb 2006

  The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.

• • Terminated Z-1103-06 FDA Unclassified (pre-2012) ·initiated 27 Jan 2006

  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.

• • Terminated Z-0888-05 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.

• • Terminated Z-0797-05 FDA Unclassified (pre-2012) ·initiated 11 Apr 2005

  The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.

• • Terminated Z-0846-05 FDA Unclassified (pre-2012) ·initiated 18 Nov 2004

  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.

510(k) Number

K002420 ↗

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. →