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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS DOPPLEX TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS DOPPLEX TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number DIOP8
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
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Brand NameDOPPLEX
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
35 portmanmoor road
splott
cardiff, CF24 5HN
UK CF24 5HN
Manufacturer (Section G)
HUNTLEIGH HEALTHCARE LTD
35 portmanmoor road
splott
cardiff, CF24 5HN
UK CF24 5HN
Manufacturer Contact
steve monks
35 portmanmoor road
splott
cardiff, CF24 -5HN
UK   CF24 5HN
MDR Report Key13418038
Report Number1000589001-2022-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIOP8
Device Catalogue NumberDIPP10
Device Lot Number107842006001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0960-2022

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