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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND X7-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND X7-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number TRANSDUCER X7-2
Device Problem Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Return of the suspect transducer is anticipated. Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported an x7-2t model transducer had an articulation issue during use. There was no injury associated with this event.
 
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Brand NameX7-2T
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
MDR Report Key11353257
MDR Text Key233474196
Report Number3019216-2021-10022
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRANSDUCER X7-2
Device Catalogue Number989605414122
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/29/2021
Event Location No Information
Date Manufacturer Received02/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
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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