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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number ALLURA XPER FD20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hair Loss (1877)
Event Date 08/01/2023
Event Type  Injury  
Event Description
It has been reported to philips that a patient suffered hair loss after a procedure using an allura xper fd20 imaging system.The customer was concerned as to the radiation dose applied.Quality assurance testing was performed by a 3rd party company and the results confirmed that the radiation dose delivered by the system was within specifications.
 
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Brand Name
ALLURA XPER FD
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
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NL  5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL   5684 PC
Manufacturer Contact
dusty leppert
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key17675999
MDR Text Key322603298
Report Number3003768277-2023-04791
Device Sequence Number1
Product Code OWB
UDI-Device Identifier00884838059054
UDI-Public00884838059054
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K130638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberALLURA XPER FD20
Device Catalogue Number722012
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/01/2023
Initial Date FDA Received09/04/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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