JOPClass II

Transducer, Ultrasonic

Cardiovascular · 21 CFR 870.2880

MDR events24All time

Recalls1All time

Registered firms29Currently listed

510(k) clearances72All time

Recent MDR events

24 adverse event reports on file

P8-2TSMay 13, 2026
InjuryShenzhen Mindray Bio-medical Electronics Co., Ltd2221819-2026-00007
P8-2TSMay 13, 2026
InjuryShenzhen Mindray Bio-medical Electronics Co., Ltd3009156722-2026-00007
ABI STUDIESMay 4, 2026
MalfunctionParks Medical25067532
P8-2TSApr 8, 2026
DeathShenzhen Mindray Bio-medical Electronics Co., Ltd3009156722-2026-00006
P8-2TSApr 8, 2026
DeathShenzhen Mindray Bio-medical Electronics Co., Ltd2221819-2026-00006
8.3MHZ PENCIL PROBE 7 FOOT ODU CONNECTORJun 24, 2025
InjuryParks Medical Electronics, Inc.22318343
9.1MHZ PENCIL PROBEJun 2, 2025
MalfunctionParks Medical Electronics, Inc.22122473
STERILE ULTRASOUND PROBE COVERNov 19, 2024
MalfunctionMedline Industries, Lp20723105
TRANSDUCER X7-2TJun 8, 2022
MalfunctionPhilips Ultrasound Inc.14631108
ROLLED PROBE COVERSep 7, 2021
MalfunctionMicrotek Medical B.v.12432222

Event type breakdown

Malfunction16

Injury5

Death2

Unspecified1

Most-reported manufacturers

Shenzhen Mindray Bio-medical Electronics Co., Ltd4 Unspecified3 Richard Wolf Gmbh3 Cook Vandergrift Inc.2 Parks Medical Electronics, Inc.2 Beckman Coulter, Inc.1 Cook Vandergrift Inc1 Medline Industries, Lp1

Recalls

1 recall events for this product code

Biosound Esaote, Inc.
TerminatedAug 8, 2014
Esaote PA230E Transducer
Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
Z-2167-2014 · View FDA record ↗

Registered firms

29 firms currently registered for this product code

510(k) clearances

72 clearances for this product code