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2026 data FDA MAUDE openFDA FDA Class II

System, Imaging, Pulsed Doppler, Ultrasonic

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §892.1550 (Radiology panel).

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FDA MAUDE casebook

openFDA event book System, Imaging, Pulsed Doppler, Ultrasonic LIGHT-BOOK · MAUDE

#437 of 1000 · 2,659 reports · 1993–2026

  • BOOK 2,659 reports
  • RANK #437 of 1000
  • DEATH 35 death-typed
  • INJ 254 injury-typed
  • MALF 2,333 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 621
  • PHOTO Intraocular Pressure…

Nearest event-volume peer: Intraocular Pressure Lowering Implant (12 report gap)

System, Imaging, Pulsed Doppler, Ultrasonic sits #437 of 1000 among tracked device types with 2,659 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

System, Imaging, Pulsed Doppler, Ultrasonic carries 87.7% MALFUNCTION-coded reports, 22.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 9.6% corpus 30.3% · below corpus mean (-20.7 pp)
  • MALF 87.7% corpus 64.8% · above corpus mean (+22.9 pp)

Lead product-problem code Unintended System Motion is 27% of coded problems · Lead manufacturer PHILIPS NORTH AMERICA LLC accounts for 100% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

System, Imaging, Pulsed Doppler, Ultrasonic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows System, Imaging, Pulsed Doppler, Ultrasonic carries 2,659 MAUDE reports, ranked #437 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 2,333 (87.7%)
Injury 254 (9.6%)
Death 35 (1.3%)
Other 27 (1.0%)
10 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

2,236 (82.5%)
Other 194 (7.2%)
Required Intervention 104 (3.8%)
Hospitalization 70 (2.6%)
Death 31 (1.1%)
H 24 (0.9%)
R 21 (0.8%)
O 7 (0.3%)
D 5 (0.2%)
L 4 (0.1%)
S 4 (0.1%)
Disability 4 (0.1%)
Life Threatening 4 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Unintended System Motion 522
Application Program Freezes or Fails to Launch 148
Material Integrity Problem 135
Adverse Event Without Identified Device or Use Problem 123
Electrical /Electronic Property Problem 95
Device Operational Issue 86
Poor Quality Image 86
Loss of Data 84
No Display/Image 84
Mechanical Jam 78
Patient Data Problem 70
Data Problem 64
Device Operates Differently Than Expected 60
Unintended Application Program Shut Down 55
Break 48
Fracture 48
Unexpected Shutdown 47
Fire 44
Material Split, Cut or Torn 44
Detachment of Device or Device Component 41

Yearly Trend

93
1993: 1
95
1995: 2
96
1996: 2
97
1997: 5
98
1998: 7
99
1999: 4
00
2000: 4
01
2001: 8
02
2002: 8
03
2003: 8
04
2004: 2
05
2005: 5
06
2006: 5
07
2007: 3
08
2008: 2
09
2009: 9
10
2010: 17
11
2011: 18
12
2012: 20
13
2013: 18
14
2014: 48
15
2015: 116
16
2016: 145
17
2017: 146
18
2018: 85
19
2019: 59
20
2020: 67
21
2021: 213
22
2022: 186
23
2023: 229
24
2024: 266
25
2025: 621
26
2026: 330

Reports rose to 621 in 2025, up from an average of 248 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Imaging, Pulsed Doppler, Ultrasonic

Top Manufacturers

PHILIPS NORTH AMERICA LLC 42

Event Locations

1,875 (70.5%)
I 520 (19.6%)
HOSPITAL 209 (7.9%)
NO INFORMATION 27 (1.0%)
OUTPATIENT DIAGNOSTIC FACILITY 16 (0.6%)
OTHER 5 (0.2%)
INVALID DATA 2 (0.1%)
UNKNOWN 2 (0.1%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Imaging, Pulsed Doppler, Ultrasonic: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,659 here).

Intraocular Pressure Lowering Implant 2,671 Staple, Fixation, Bone 2,647 Prosthesis, Hip, Hemi-, Femoral, Metal 2,683 Handpiece 2,629

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Adhesive 35 Balloon Aortic Valvuloplasty 35 Electrocardiograph 35 Fluid Jet Removal System 35

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System, Imaging, Pulsed Doppler, Ultrasonic are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Imaging, Pulsed Doppler, Ultrasonic; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.