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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; SYSTEM, X-RAY, ANGIOGRAPHIC
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number ALLURA XPER FD20 BIPLANE
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2024
Event Type  malfunction  
Event Description
It was reported to philips that the system failed to bootup, it was stuck at 00:00.The device was outside of clinical use at the time of reported event.No harm was reported to philips.The philips field service engineer (fse) replaced the flexvision pc and installed the software.After replacement of the flexvision pc and installation of the software, the system was returned to use in good working order.
 
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Brand Name
ALLURA XPER FD
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL  5684 PC
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
veenpluis 6
best 5684 PC
NL   5684 PC
Manufacturer Contact
derrick massuri
3000 minuteman rd
andover, MA 01810
6172455900
MDR Report Key19193380
MDR Text Key341195272
Report Number3003768277-2024-02476
Device Sequence Number1
Product Code IZI
UDI-Device Identifier00884838059061
UDI-Public00884838059061
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130842
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 BIPLANE
Device Catalogue Number722013
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/03/2024
Initial Date FDA Received04/26/2024
Date Device Manufactured03/24/2014
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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