PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Transducer, Ultrasonic, Diagnostic

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 §892.1570 (Radiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Transducer, Ultrasonic, Diagnostic LIGHT-BOOK · MAUDE

#355 of 1000 · 3,948 reports · 1994–2026

  • BOOK 3,948 reports
  • RANK #355 of 1000
  • DEATH 23 death-typed
  • INJ 324 injury-typed
  • MALF 3,525 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 988
  • PHOTO File

Nearest event-volume peer: File, Pulp Canal, Endodontic (23 report gap)

Transducer, Ultrasonic, Diagnostic sits #355 of 1000 among tracked device types with 3,948 MAUDE reports spanning 1994–2026. 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

Transducer, Ultrasonic, Diagnostic carries 89.3% MALFUNCTION-coded reports, 24.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 8.2% corpus 30.3% · below corpus mean (-22.1 pp)
  • MALF 89.3% corpus 64.8% · above corpus mean (+24.5 pp)

Lead product-problem code Poor Quality Image is 42% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 49% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Transducer, Ultrasonic, Diagnostic in the event-volume neighbourhood

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

reports

What this shows Transducer, Ultrasonic, Diagnostic carries 3,948 MAUDE reports, ranked #355 of 1000.

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

Event Types

Malfunction 3,525 (89.3%)
Injury 324 (8.2%)
Other 58 (1.5%)
Death 23 (0.6%)
18 (0.5%)

Patient Outcomes

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

3,134 (78.3%)
Other 555 (13.9%)
Required Intervention 151 (3.8%)
Hospitalization 56 (1.4%)
R 32 (0.8%)
Death 21 (0.5%)
O 14 (0.3%)
Life Threatening 13 (0.3%)
L 10 (0.2%)
H 7 (0.2%)
S 5 (0.1%)
Congenital Anomaly 3 (0.1%)
Disability 3 (0.1%)
D 1 (0.0%)

Top Product Problems

Poor Quality Image 1,275
Device Displays Incorrect Message 325
Break 247
Adverse Event Without Identified Device or Use Problem 120
Device Operates Differently Than Expected 115
Leak/Splash 108
Material Deformation 106
No Display/Image 100
Material Twisted/Bent 90
Detachment of Device or Device Component 79
Fluid/Blood Leak 75
Detachment Of Device Component 48
Material Split, Cut or Torn 48
No Apparent Adverse Event 48
Use of Device Problem 48
Defective Component 47
Deformation Due to Compressive Stress 45
Mechanical Problem 41
Entrapment of Device 40
Material Puncture/Hole 40

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 2
97
1997: 14
98
1998: 6
99
1999: 13
00
2000: 10
01
2001: 11
02
2002: 15
03
2003: 14
04
2004: 22
05
2005: 16
06
2006: 20
07
2007: 16
08
2008: 39
09
2009: 23
10
2010: 30
11
2011: 34
12
2012: 29
13
2013: 38
14
2014: 43
15
2015: 183
16
2016: 269
17
2017: 412
18
2018: 130
19
2019: 119
20
2020: 116
21
2021: 146
22
2022: 87
23
2023: 138
24
2024: 988
25
2025: 575
26
2026: 387

Reports in 2025 (575) held close to the prior two-year average of 563.

Related Entities for Transducer, Ultrasonic, Diagnostic

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 663
C.R. BARD, INC. (BASD) -3006260740 322
OLYMPUS MEDICAL SYSTEMS CORP. 138
BOSTON SCIENTIFIC CORPORATION 118
BARD ACCESS SYSTEMS 115

Event Locations

2,607 (66.0%)
I 856 (21.7%)
HOSPITAL 360 (9.1%)
NO INFORMATION 76 (1.9%)
HOME 11 (0.3%)
OTHER 11 (0.3%)
INVALID DATA 8 (0.2%)
UNKNOWN 8 (0.2%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs C.R. BARD, INC. (BASD) -3006260740 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Transducer, Ultrasonic, Diagnostic: 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 (3,948 here).

File, Pulp Canal, Endodontic 3,925 Suture, Nonabsorbable, Silk 3,979 Orthosis, Spinal Pedicle Fixation 3,989 Transducer, Blood-Pressure, Extravascular 3,904

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Electrode, Electrocardiograph 23 Gastrointestinal Tubes With Enteral Specifi… 23 Regulator, Pressure, Gas Cylinder 23

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

Disclaimer: MAUDE figures for Transducer, Ultrasonic, Diagnostic 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 Transducer, Ultrasonic, Diagnostic; 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.