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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE OPTIMA XR200AMX; SYSTEM, X-RAY, MOBILE
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GE HEALTHCARE OPTIMA XR200AMX; SYSTEM, X-RAY, MOBILE Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2017
Event Type  malfunction  
Event Description
On three separate occasions within approximately a 12 month period, portable ge optima x-ray machine failed to take exposures.Three battery packs had to be replaced in the period of 1 year at (b)(6) - the 3rd replacement ge replaced free of charge.Manufacturer response for portable x-ray machine, optima xr200amx (per site reporter): ge serviced the machine and replaced parts as needed.
 
Event Description
On three separate occasions within approximately a 12 month period, portable ge optima x-ray machine failed to take exposures.Three battery packs had to be replaced in the period of 1 year at a cost of (b)(4)- the 3rd replacement ge replaced free of charge.Manufacturer response for portable x-ray machine, optima xr200amx (per site reporter): ge serviced the machine and replaced parts as needed.
 
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Brand Name
OPTIMA XR200AMX
Type of Device
SYSTEM, X-RAY, MOBILE
Manufacturer (Section D)
GE HEALTHCARE
3000 n grandview blvd.
waukesha WI 53188
MDR Report Key6479684
MDR Text Key72363362
Report Number6479684
Device Sequence Number1
Product Code IZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/29/2017,04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2017
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer03/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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