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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-12-19Z-1018-2026Class IIOpen, ClassifiedThere is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.22 systemscode info di
2024-05-10Z-2041-2024Class IIOpen, ClassifiedThe 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.Distribution: US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR153code info di
2021-05-21Z-2046-2021Class IIOpen, ClassifiedThe MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.Distribution: US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.clearance family
2016-04-14Z-2135-2016Class IITerminatedA potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.Distribution: US Nationwide Distribution33 unitsclearance family
2012-10-15Z-1101-2013Class IITerminatedIt was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD MoniDistribution: USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.27 unitsclearance family
Regulatory clearances
  • 510(k)K191128Substantially equivalent (SESE) · 2019-06-26clearance family
  • 510(k)K172878Substantially equivalent (SESE) · 2017-11-17clearance family
  • 510(k)K152371Substantially equivalent (SESE) · 2015-10-23clearance family
  • 510(k)K143008Substantially equivalent (SESE) · 2015-04-09clearance family
  • 510(k)K132160Substantially equivalent (SESE) · 2013-10-16clearance family
  • 510(k)K120487Substantially equivalent (SESE) · 2012-05-23clearance family
  • 510(k)K113093Substantially equivalent (SESE) · 2012-01-13clearance family

Predicate lineage

K120487

Cited as predicate by: K132160, K151091

Cited as predicate by: K143008

Cited as predicate by: K150427, K152371, K191128

Cited as predicate by: K160632, K162183, K172878, K182282

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2014-09-19NAINo action indicatedCanon Components, Inc. (Factory Site)0
2014-09-17NAINo action indicatedCanon Inc.0
2014-09-17NAINo action indicatedCanon Inc.0
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