DIAGNOSTIC ULTRASOUND SYSTEM · recalls, adverse events, clearances

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

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2017-05-01	Z-2710-2017	Class II	Terminated	When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.Distribution: Nationwide Distribution	90 units	clearance family
2017-05-01	Z-2711-2017	Class II	Terminated	When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.Distribution: Nationwide Distribution	307 units	clearance family

Regulatory clearances

510(k)K151451Substantially equivalent (SESE) · 2015-07-09clearance family
510(k)K141459Substantially equivalent (SESE) · 2014-10-28clearance family
510(k)K133761Substantially equivalent (SESE) · 2014-04-22clearance family
510(k)K123992Substantially equivalent (SESE) · 2013-02-06clearance family
510(k)K121422Substantially equivalent (SESE) · 2012-08-16clearance family
510(k)K110870Substantially equivalent (SESE) · 2011-10-04clearance family

Predicate lineage

K110870

Cited as predicate by: K121422

K121422

Cited as predicate by: K123992, K132677, K132685, K141459, K151451

K123992
- K103629
  - K092179
- K121422

Cited as predicate by: K131507, K133761, K141459, K151451

K133761
- K123992
  - K103629
    - K092179
  - K121422

Cited as predicate by: K141459, K142517, K151451, K161999

K141459

Cited as predicate by: K151451, K171105

K151451

Cited as predicate by: K161843, K162155, K162187, K163082, K163702, K172276, K182679, K191663

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

Date	Type	Outcome	Facility
2014-09-19	NAI	No action indicated	Canon Components, Inc. (Factory Site)
2014-09-17	NAI	No action indicated	Canon Inc.
2014-09-17	NAI	No action indicated	Canon Inc.

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