ALLURA XPER FD

INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

This device is manufactured by PHILIPS, PHILIPS MEDICAL SYSTEMS, PHILIPS MEDICAL SYSTEMS NEDERLAND BV.

The following problems were reported about this device:

Year Description Events/year Type
2024 Laceration(s) 1 Patient
2024 Insufficient Information 6 Patient
2024 Fall 3 Patient
2024 Unintended System Motion 3 Device
2024 Unexpected Shutdown 1 Device
2024 Smoking 1 Device
2024 Radiation Output Problem 1 Device
2024 Radiation Output Failure 318 Device
2024 Positioning Failure 82 Device
2024 Poor Quality Image 2 Device
2024 No Display/Image 39 Device
2024 No Device Output 1 Device
2024 Malposition of Device 1 Device
2024 Image Display Error/Artifact 1 Device
2024 Fire 1 Device
2024 Failure to Power Up 6 Device
2024 Erratic or Intermittent Display 1 Device
2024 Environmental Particulates 1 Device
2024 Display or Visual Feedback Problem 3 Device
2024 Difficult or Delayed Activation 2 Device
2024 Detachment of Device or Device Component 6 Device
2024 Activation Failure 389 Device
2023 Insufficient Information 15 Patient
2023 Hair Loss 1 Patient
2023 Appropriate Term / Code Not Available 1 Patient
2023 Use of Device Problem 2 Device
2023 Unstable 1 Device
2023 Unintended System Motion 7 Device
2023 Unexpected/Unintended Radiation Output 2 Device
2023 Structural Problem 1 Device
2023 Sparking 1 Device
2023 Separation Failure 1 Device
2023 Radiation Output Failure 310 Device
2023 Positioning Problem 1 Device
2023 Positioning Failure 127 Device
2023 Poor Quality Image 1 Device
2023 Output Problem 5 Device
2023 Noise, Audible 1 Device
2023 No Display/Image 74 Device
2023 No Device Output 2 Device
2023 Mechanical Jam 1 Device
2023 Key or Button Unresponsive/not Working 1 Device
2023 Insufficient Information 2 Device
2023 Installation-Related Problem 1 Device
2023 Image Display Error/Artifact 1 Device
2023 Fire 2 Device
2023 Failure to Power Up 3 Device
2023 Erratic or Intermittent Display 2 Device
2023 Electrical Shorting 1 Device
2023 Difficult or Delayed Positioning 1 Device
2023 Difficult or Delayed Activation 3 Device
2023 Device Displays Incorrect Message 1 Device
2023 Detachment of Device or Device Component 4 Device
2023 Data Problem 1 Device
2023 Computer Software Problem 2 Device
2023 Appropriate Term/Code Not Available 1 Device
2023 Adverse Event Without Identified Device or Use Problem 1 Device
2023 Activation, Positioning or Separation Problem 1 Device
2023 Activation Problem 1 Device
2023 Activation Failure 560 Device
2022 Insufficient Information 7 Patient
2022 Unstable 1 Device
2022 Unintended System Motion 3 Device
2022 Unintended Movement 1 Device
2022 Unexpected Shutdown 2 Device
2022 Structural Problem 1 Device
2022 Sparking 1 Device
2022 Smoking 2 Device
2022 Radiation Output Failure 151 Device
2022 Problem with Software Installation 1 Device
2022 Positioning Failure 51 Device
2022 Output Problem 3 Device
2022 No Display/Image 38 Device
2022 No Device Output 12 Device
2022 Mechanical Problem 1 Device
2022 Mechanical Jam 1 Device
2022 Malposition of Device 1 Device
2022 Lack of Maintenance Documentation or Guidelines 1 Device
2022 Key or Button Unresponsive/not Working 2 Device
2022 Intermittent Loss of Power 1 Device
2022 Intermittent Communication Failure 1 Device
2022 Insufficient Information 2 Device
2022 Image Display Error/Artifact 1 Device
2022 Fire 4 Device
2022 Failure to Reset 1 Device
2022 Failure to Read Input Signal 1 Device
2022 Failure to Power Up 6 Device
2022 Failure to Advance 3 Device
2022 Erratic or Intermittent Display 2 Device
2022 Entrapment of Device 1 Device
2022 Difficult or Delayed Positioning 2 Device
2022 Difficult or Delayed Activation 2 Device
2022 Device Dislodged or Dislocated 1 Device
2022 Detachment of Device or Device Component 4 Device
2022 Computer Operating System Problem 1 Device
2022 Circuit Failure 1 Device
2022 Battery Problem 1 Device
2022 Activation, Positioning or Separation Problem 1 Device
2022 Activation Failure 202 Device