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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information has been requested but not yet received. There are no additional device identification numbers. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported to ge healthcare that axial t1 images of a brain mri exam demonstrated a right to left image flip, resulting in incorrectly displayed anatomy. The patient had a known left side brain tumor, which made the issue detectable to the user. No injury or misdiagnosis occurred due to this issue. An investigation has been initiated.
 
Manufacturer Narrative
Ge healthcare's investigation has determined that the incident occurred due to the latest on-site software version not being reinstalled after service activities were performed that required software to be reloaded. Under specific conditions, this software configuration resulted in an image flip left/right. Ge healthcare is initiating an action in the field as reported to the fda under correction number 2183553-06/13/18-001-c on june 13, 2018.
 
Manufacturer Narrative
Corrected data: ge healthcare's investigation has determined that the incident occurred due to the latest on-site software version not being reinstalled after service activities were performed that required software to be reloaded. Under specific conditions, this software configuration resulted in an image flip left/right. Ge healthcare is initiating an action in the field as reported to the fda under correction number 2183553-06/13/18-003-c on june 13, 2018. Correction/removal report number: 2183553-06/13/18-003-c.
 
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Brand NameSIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
Type of DeviceNUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3200 n grandview blvd.
waukesha, WI
Manufacturer Contact
jacqui budde
3200 n. grandview blvd.
waukesha, WI 
MDR Report Key7374792
MDR Text Key103684446
Report Number2183553-2018-00005
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Radiologic Technologist
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUDI NOT REQUIRED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2183553-06/13/18-003-C

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