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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605361911
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported their x7-2t model transducer was not fully adjusting the articulation angle. There was no injury associated with this event.
 
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Brand NameX7-2T TRANSDUCER (MTEE)
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key9405817
MDR Text Key175918175
Report Number3019216-2019-00084
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605361911
Device Lot NumberB0N3FY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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