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2026 data FDA MAUDE openFDA FDA Class II

System, Imaging, Pulsed Echo, 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 §892.1560 (Radiology panel).

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FDA MAUDE casebook

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

#280 of 1000 · 6,516 reports · 1993–2026

  • BOOK 6,516 reports
  • RANK #280 of 1000
  • DEATH 17 death-typed
  • INJ 239 injury-typed
  • MALF 6,209 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 640
  • PHOTO Separator

Nearest event-volume peer: Separator, Automated, Blood Cell, Diagnostic (59 report gap)

System, Imaging, Pulsed Echo, Ultrasonic sits #280 of 1000 among tracked device types with 6,516 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 Echo, Ultrasonic carries 95.3% MALFUNCTION-coded reports, 30.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 3.7% corpus 30.3% · below corpus mean (-26.6 pp)
  • MALF 95.3% corpus 64.8% · above corpus mean (+30.5 pp)

Lead product-problem code Poor Quality Image is 27% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 74% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

System, Imaging, Pulsed Echo, 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 Echo, Ultrasonic carries 6,516 MAUDE reports, ranked #280 of 1000.

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

Event Types

Malfunction 6,209 (95.3%)
Injury 239 (3.7%)
Other 42 (0.6%)
Death 17 (0.3%)
9 (0.1%)

Patient Outcomes

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

Other 3,293 (50.4%)
3,075 (47.0%)
Required Intervention 93 (1.4%)
Hospitalization 17 (0.3%)
Death 15 (0.2%)
R 14 (0.2%)
O 7 (0.1%)
Disability 7 (0.1%)
L 6 (0.1%)
Life Threatening 5 (0.1%)
H 2 (0.0%)
Congenital Anomaly 2 (0.0%)
S 1 (0.0%)

Top Product Problems

Poor Quality Image 1,782
Retraction Problem 1,037
No Apparent Adverse Event 679
Defective Component 526
Battery Problem 360
Loss of Power 350
Break 326
Unexpected Shutdown 326
Application Program Freezes or Fails to Launch 245
No Display/Image 146
Incorrect Measurement 139
Sharp Edges 124
Data Problem 111
Computer Software Problem 106
Image Display Error/Artifact 91
Contamination /Decontamination Problem 87
Device Operates Differently Than Expected 80
Transducer overheating 60
Inappropriate/Inadequate Shock/Stimulation 50
Loss of Data 50

Yearly Trend

93
1993: 1
95
1995: 1
96
1996: 7
97
1997: 25
98
1998: 6
99
1999: 17
00
2000: 25
01
2001: 244
02
2002: 20
03
2003: 13
04
2004: 5
05
2005: 7
06
2006: 7
07
2007: 39
08
2008: 20
09
2009: 27
10
2010: 20
11
2011: 58
12
2012: 78
13
2013: 436
14
2014: 304
15
2015: 268
16
2016: 254
17
2017: 238
18
2018: 368
19
2019: 537
20
2020: 498
21
2021: 617
22
2022: 511
23
2023: 527
24
2024: 640
25
2025: 492
26
2026: 206

Reports in 2025 (492) held close to the prior two-year average of 584.

Related Entities for System, Imaging, Pulsed Echo, Ultrasonic

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 2,483
BARD ACCESS SYSTEMS 758
ALCON - IRVINE TECHNOLOGY CENTER 123

Event Locations

3,736 (57.3%)
HOSPITAL 1,433 (22.0%)
I 1,213 (18.6%)
OUTPATIENT DIAGNOSTIC FACILITY 55 (0.8%)
OTHER 20 (0.3%)
NO INFORMATION 17 (0.3%)
OUTPATIENT TREATMENT FACILITY 12 (0.2%)
UNKNOWN 11 (0.2%)
AMBULATORY SURGICAL FACILITY 7 (0.1%)
NOT APPLICABLE 5 (0.1%)
HOME 4 (0.1%)
INVALID DATA 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs BARD ACCESS SYSTEMS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Imaging, Pulsed Echo, 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 (6,516 here).

Separator, Automated, Blood Cell, Diagnostic 6,575 Tube, Tracheostomy 6,588 Ureteroscope And Accessories, Flexible/Rigid 6,637 Hearing Aid, Bone Conduction, Implanted 6,678

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17 Counter, Differential Cell 17

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

Disclaimer: MAUDE figures for System, Imaging, Pulsed Echo, 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 Echo, 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.