Gyroscan Intera (R7.5)

• • Terminated Z-1024-2016 FDA Class II ·initiated 6 Jul 2015

  Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.

• • Terminated Z-0469-2011 FDA Unclassified (pre-2012) ·initiated 1 May 2009

  Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.

• • Terminated Z-0982-2007 FDA Unclassified (pre-2012) ·initiated 30 Apr 2007

  Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

• • Terminated Z-1488-04 FDA Unclassified (pre-2012) ·initiated 20 Aug 2004 ·on shared 510(k) K001796

  Potential for patient burn

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

510(k) Number

K001796 ↗

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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