# K031333: Philips Integris Allura Flat Detector Release 1.2

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: May 13, 2003 after 15 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890348 (1989). 7 ancestors in all.
113 later devices descend from it; 2 cite it directly.
10 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022899: Philips Integris Allura Flat Detector Release 1.0, Philips Medical Systems North America Co. (2002)
- (no number) GE Innova 4100 system: named in the summary without a submission number

## Most influential descendants
- K041949: Allura Xper FD10 (2004), 64 descendants of its own
- K031836: Philips Fresco Release 1 (2003), 51 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own

## Recalls of this device
- Jan 13, 2025 · Class II · Z-1077-2025: 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-1151-2024: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
- 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
- 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
- Jul 16, 2018 · Class II · Z-3213-2018: 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-3214-2018: 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-3217-2018: 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-3220-2018: 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-3219-2018: 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-3215-2018: 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-3218-2018: 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-3216-2018: 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-1820-2017: 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
- 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
- Sep 24, 2014 · Class II · Z-1280-2016: Loss of key image functionality due to a bent pedal of the Footswitch.
- 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.
- 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-0344-2009: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Oct 23, 2008 · Not classified · Z-2471-2010: 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
- Dec 14, 2006 · Not classified · Z-0370-2007: Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Oct 12, 2006 · Not classified · Z-0165-2007: Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
- Feb 6, 2006 · Not classified · Z-0581-06: Potential lock-up of system requiring reboot of system.
- Oct 12, 2005 · Not classified · Z-0206-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Oct 12, 2005 · Not classified · Z-0207-06: Potential for high voltage exposure involving the injector interface connector of patient support tables.

## Indications for use
The Philips lntegris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, intewentional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

Source page: https://510kreport.com/device/K031333
Methodology: https://510kreport.com/methodology