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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC REVOLUTION XR/D SYSTEM, X-RAY, STATIONARY

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GE MEDICAL SYSTEMS, LLC REVOLUTION XR/D SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 2213251
Device Problems Installation-Related Problem (2965); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare investigation into the reported event has been initiated and is ongoing. A follow-up report will be submitted when the investigation has been completed.
 
Event Description
On (b)(6) 2021, the customer at (b)(6) medical center in the usa reported they were having collimation and alignment issues on their revolution xr/d fixed radiographic system. The ge field engineer arrived at the site to investigate the issue and identified the collimator rotation lever was jammed between the collimator and the collimator mounting plate. This symptom can be caused by a collimator installation error of not fully depressing the collimator rotation lever when mounting/installing the collimator to the mounting flange which was identified as a reportable malfunction.
 
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Brand NameREVOLUTION XR/D
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, WI 53188
Manufacturer (Section G)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, WI 53188
Manufacturer Contact
steven walczak
3000 north grandview boulevard
waukesha, WI 53188-1696
MDR Report Key12104523
MDR Text Key262897164
Report Number2126677-2021-00043
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2213251
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 Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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