# K033737: Allura Xper FD20

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Dec 9, 2003 after 11 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 54 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002016 (2000). 1 ancestor in all.
26 later devices descend from it; 5 cite it directly.
6 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002016: Philips Integris Allura, Philips Medical Systems North America, Inc. (2000) Summary page 1.

## Most influential descendants
- K102005: Allura Xper or Table Series (2010), 24 descendants of its own
- K130638: Alluraclarity Xper FD Series X-Ray System (2013), 18 descendants of its own
- K133292: Allura Xper FD; or Table (2014), 15 descendants of its own
- K141979: Allura Xper FD Series / Allura Xper or Table Series (2014), 13 descendants of its own
- K162148: Allura Xper R9 (2016), 8 descendants of its own

## Recalls of this device
- Jan 13, 2025 · Class I · Z-1160-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1144-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1159-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1151-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1150-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1148-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1154-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1158-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1147-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1142-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1143-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1149-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class I · Z-1145-2025: Possibility of the patient falling from the table related to the mattress used on the patient table.
- Jan 13, 2025 · Class II · Z-1080-2025: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a fin
- Jan 2, 2024 · Class II · Z-1144-2024: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the 
- Feb 19, 2019 · Class II · Z-1141-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This
- Feb 19, 2019 · Class II · Z-1140-2019: Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This
- Jul 16, 2018 · Class II · Z-3222-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Jul 16, 2018 · Class II · Z-3224-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Jul 16, 2018 · Class II · Z-3221-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Jul 16, 2018 · Class II · Z-3223-2018: There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceilin
- Mar 22, 2017 · Class II · Z-1822-2017: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in th
- Dec 9, 2016 · Class II · Z-1061-2017: System may lock up.
- Dec 9, 2016 · Class II · Z-1062-2017: System may lock up.
- Dec 1, 2016 · Class II · Z-0922-2017: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
- Nov 3, 2015 · Class II · Z-0764-2016: Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances
- Jul 6, 2015 · Class II · Z-0810-2016: The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
- Feb 3, 2015 · Class II · Z-0346-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0349-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0354-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0353-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0348-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0350-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0351-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0352-2016: Monitor Ceiling Suspension system may fall
- Feb 3, 2015 · Class II · Z-0347-2016: Monitor Ceiling Suspension system may fall
- Sep 24, 2014 · Class II · Z-1280-2016: Loss of key image functionality due to a bent pedal of the Footswitch.
- Jul 8, 2014 · Class II · Z-0181-2015: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
- Jul 8, 2014 · Class II · Z-0182-2015: Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
- Apr 2, 2012 · Not classified · Z-1462-2012: The monitor Ceiling suspension may fail, which may cause the monitor to drop.
- Jul 8, 2011 · Not classified · Z-2976-2011: System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period.
- Nov 4, 2010 · Not classified · Z-1368-2011: Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal 
- Feb 4, 2010 · Not classified · Z-2448-2010: A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power convert
- Feb 4, 2010 · Not classified · Z-2449-2010: A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converter
- Dec 10, 2008 · Not classified · Z-0348-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Dec 10, 2008 · Not classified · Z-0349-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Oct 23, 2008 · Not classified · Z-2475-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Oct 23, 2008 · Not classified · Z-2476-2010: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and henc
- Sep 24, 2007 · Not classified · Z-0329-2008: Inaccurate anatomical measurements when using the optional SmartMask feature
- Sep 24, 2007 · Not classified · Z-0330-2008: Inaccurate anatomical measurements when using the optional SmartMask feature

## Indications for use
The Allura Xper FD20 is intended for: o Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. o Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomiss), pacemaker implantations, and electrophysiology (EP). » Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

Source page: https://510kreport.com/device/K033737
Methodology: https://510kreport.com/methodology