DXKClass II

Echocardiograph

Cardiovascular · 21 CFR 870.2330

MDR events21All time

Recalls0All time

Registered firms10Currently listed

510(k) clearances78All time

Recent MDR events

21 adverse event reports on file

ULTRA ICE PLUS CATHETERApr 22, 2024
MalfunctionBoston Scientific CorporationMW5154100
ULTRA ICE PLUS - PIMar 22, 2021
MalfunctionBoston Scientific Corporation2134265-2021-03611
ULTRA ICE PLUSApr 14, 2020
InjuryBoston Scientific Corporation2134265-2020-05058
ULTRA ICE PLUSApr 14, 2020
InjuryBoston Scientific Corporation2134265-2020-05059
ULTRA ICE PLUS - PISep 23, 2019
InjuryBoston Scientific Corporation2134265-2019-11532
ULTRA ICE PLUS¿May 22, 2018
MalfunctionBoston Scientific - Costa Rica (coyol)2134265-2018-04816
ULTRA ICE PLUS¿Mar 22, 2018
MalfunctionBoston Scientific - Costa Rica (coyol)2134265-2018-02275
ULTRA ICE PLUS¿Mar 15, 2018
MalfunctionBoston Scientific - Costa Rica (coyol)2134265-2018-01975
ULTRA ICE PLUS¿Mar 6, 2018
MalfunctionBoston Scientific - Costa Rica (coyol)2134265-2018-01394
ULTRA ICE PLUS¿Aug 15, 2017
InjuryBoston Scientific - Costa Rica (coyol)2134265-2017-07872

Event type breakdown

Malfunction13

Injury6

Unspecified1

Other1

Most-reported manufacturers

Boston Scientific - Costa Rica (coyol)7 Boston Scientific Corporation5 Unspecified2 Unk2 Diasonics1 Ge Medical1 Ge Medical Systems1 Ge Vingmed Ultrasound As1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

10 firms currently registered for this product code

510(k) clearances

78 clearances for this product code