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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
2022-09-29Z-0198-2023Class IIOpen, ClassifiedAfter completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.Distribution: US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL65clearance family
Regulatory clearances
  • 510(k)K212960Substantially equivalent (SESE) · 2022-03-22clearance family
  • 510(k)K202364Substantially equivalent (SESE) · 2020-10-15clearance family
  • 510(k)K191663Substantially equivalent (SESE) · 2019-09-18clearance family

Predicate lineage

Cited as predicate by: K212960

Cited as predicate by: K221235, K253597

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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