Vantage Titan with Helios Gradient Model Mrt-1504/Us

• • Ongoing Z-2041-2024 FDA Class II ·initiated 10 May 2024

  The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

• • Ongoing Z-1250-2024 FDA Class II ·initiated 29 Jan 2024

  For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

• • Ongoing Z-2044-2021 FDA Class II ·initiated 21 May 2021

  The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

510(k) Number

K122613 ↗

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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