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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE GE LIGHTSPEED VCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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GE HEALTHCARE GE LIGHTSPEED VCT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number LIGHTSPEED VCT
Device Problems Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problem Insufficient Information (4580)
Event Date 08/29/2021
Event Type  malfunction  
Event Description
This is more a general concern not patient specific.In general, this is one of the best computed tomography (ct) scanner that i am aware of.The only time it seems to fail are when the switches fail.The switches get broke or damaged in time as the gurneys hit the table or when heavy patients are put on and off the table.When these switches break it causes the table not to operate therefore the ct has to be shut down.In this hospital we only have one ct so we have to send our patients to another hospital causing a delay in patient care.It would be nice if somehow these switches were either more rugged or protected from damage.Manufacturer response for ct, ge (per site reporter).They come out and repair the device, but there is no intended upgrade at this time.
 
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Brand Name
GE LIGHTSPEED VCT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
GE HEALTHCARE
3000 n. grandview blvd
waukesha WI 53188
MDR Report Key12445700
MDR Text Key270587680
Report Number12445700
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLIGHTSPEED VCT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/07/2021
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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