Magnetom Trio System

• • Terminated Z-2021-2011 FDA Unclassified (pre-2012) ·initiated 3 Mar 2011

  Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

• 2 recalls, same reason

  • Terminated Z-1404-04 FDA Unclassified (pre-2012) ·initiated 28 Jul 2004
  • Terminated Z-1403-04 FDA Unclassified (pre-2012) ·initiated 28 Jul 2004

  An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

• • Terminated Z-0521-04 FDA Unclassified (pre-2012) ·initiated 18 Dec 2003

  tissue roll can become magnetic

510(k) Number

K013586 ↗

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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  Class II

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  Class II

  FDA 510(k) K020353 Active Cleared 13 Feb 2002

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  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

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  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

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  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

• Somatom P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

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