Panorama 1.0T

• • Ongoing Z-0505-2024 FDA Class I ·initiated 17 Nov 2023

  Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.

• 2 recalls, same reason

  • Terminated Z-0898-2019 FDA Class II ·initiated 21 Dec 2018
  • Terminated Z-0917-2019 FDA Class II ·initiated 21 Dec 2018

  There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

• • Terminated Z-1434-2018 FDA Class II ·initiated 16 Mar 2018

  Potential risk for helium gas inside the MR examination room during a magnet quench

• • Terminated Z-1458-2011 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010

  In the ExamCard MobiFlex the Patient Position is "Prone" which must be "Supine". The result is mislabeling of left and right side of the patient. If this is not detected by the operator there is a risk of wrong treatment or the need of additional X-RAY during treatment.

• • Terminated Z-0794-2011 FDA Unclassified (pre-2012) ·initiated 12 May 2009

  The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.

• • Terminated Z-0984-2007 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.

510(k) Number

K041602 ↗

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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