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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
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
2024-01-29Z-1248-2024Class IIOpen, ClassifiedFor 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.Distribution: Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.118code info di
Regulatory clearances
  • 510(k)K253625Substantially equivalent (SESE) · 2026-03-27clearance family
  • 510(k)K250901Substantially equivalent (SESE) · 2025-07-22clearance family
  • 510(k)K240238Substantially equivalent (SESE) · 2024-04-12clearance family
  • 510(k)K222968Substantially equivalent (SESE) · 2022-10-25clearance family
  • 510(k)K220335Substantially equivalent (SESE) · 2022-04-05clearance family
  • 510(k)K211633Substantially equivalent (SESE) · 2021-07-22clearance family
  • 510(k)K210340Substantially equivalent (SESE) · 2021-04-01clearance family
  • 510(k)K202767Substantially equivalent (SESE) · 2021-01-15clearance family
  • 510(k)K203053Substantially equivalent (SESE) · 2020-12-02clearance family
  • 510(k)K202210Substantially equivalent (SESE) · 2020-09-22clearance family
  • 510(k)K193097Substantially equivalent (SESE) · 2020-07-14clearance family
  • 510(k)K193021Substantially equivalent (SESE) · 2020-06-03clearance family
  • 510(k)K191662Substantially equivalent (SESE) · 2019-07-23clearance family
  • 510(k)K182282Substantially equivalent (SESE) · 2018-10-19clearance family

Predicate lineage

K191662

Cited as predicate by: K253625

Cited as predicate by: K202767, K203053

Cited as predicate by: K210340, K211633

Cited as predicate by: K211633, K220018, K220335

Cited as predicate by: K213305, K220018, K220335

Cited as predicate by: K222968

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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