# K002016: Philips Integris Allura

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Sep 6, 2000 after 65 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 3 cite it directly.
6 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own

## Recalls of this device
- Aug 22, 2024 · Class II · Z-3167-2024: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Oct 4, 2023 · Class II · Z-0227-2024: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance S
- Dec 30, 2019 · Class II · Z-1487-2020: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
- Dec 30, 2019 · Class II · Z-1488-2020: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
- Nov 3, 2015 · Class II · Z-0726-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0727-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0728-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Nov 3, 2015 · Class II · Z-0729-2016: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Aug 8, 2014 · Class II · Z-0022-2015: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.
- Dec 14, 2006 · Not classified · Z-0366-2007: 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, 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.
- Jul 27, 2005 · Not classified · Z-0022-06: 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immed

Source page: https://510kreport.com/device/K002016
Methodology: https://510kreport.com/methodology