Integris Allura

• • Ongoing Z-3167-2024 FDA Class II ·initiated 22 Aug 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.

• • Ongoing Z-0227-2024 FDA Class II ·initiated 4 Oct 2023

  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 Spacer (Tube-spacer) is missing.

• 2 recalls, same reason

  • Terminated Z-1487-2020 FDA Class II ·initiated 30 Dec 2019
  • Terminated Z-1488-2020 FDA Class II ·initiated 30 Dec 2019

  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.

• 4 recalls, same reason

  • Terminated Z-0729-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0727-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0726-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0728-2016 FDA Class II ·initiated 3 Nov 2015

  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.

• • Terminated Z-0022-2015 FDA Class II ·initiated 8 Aug 2014

  Philips had discovered through a field service testing where a device failed to comply with a Federal standard.

• • Terminated Z-0366-2007 FDA Unclassified (pre-2012) ·initiated 14 Dec 2006 ·on shared 510(k) K002016

  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.

• 2 recalls, same reason

  • Terminated Z-0207-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005 ·on shared 510(k) K002016
  • Terminated Z-0206-06 FDA Unclassified (pre-2012) ·initiated 12 Oct 2005 ·on shared 510(k) K002016

  Potential for high voltage exposure involving the injector interface connector of patient support tables.

• • Terminated Z-0022-06 FDA Unclassified (pre-2012) ·initiated 27 Jul 2005 ·on shared 510(k) K002016

  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 immediately upon release of the joystick.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

Philips Integris Allura

510(k) Number

K002016 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K900660 Active Cleared 13 Mar 1990

• Integris 3D-Ra, Release 4.2

  Class II

  FDA 510(k) K040254 Active Cleared 19 Feb 2004

• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

  Class II

  FDA 510(k) K890351 Active Cleared 15 Jun 1989

• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

See all devices from Philips Medical Systems North America, Inc. →

• What types of medical procedures is the Philips Integris Allura designed to support with its imaging capabilities?

  The Philips Integris Allura is specifically designed for high-resolution fluoroscopic imaging during angiographic procedures. It provides real-time visualization to assist in minimally invasive interventions, including coronary and peripheral vascular diagnostics and treatments. This makes it particularly useful for procedures like coronary angiography, stent placement, and peripheral vascular interventions.

• Is the Philips Integris Allura a single-use or reusable device, and what does this mean for maintenance and cleaning?

  The Philips Integris Allura is a reusable medical instrument. This means it is intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance procedures. Reusability helps ensure cost-effectiveness and reduces waste, but it also requires adherence to strict protocols to maintain sterility and functionality between uses.

• Are there multiple model variants of the Philips Integris Allura, and how can I identify the specific variant I need?

  Yes, the Philips Integris Allura comes in multiple model variants, each associated with specific regulatory registration numbers (e.g., 3005706667, 3003768277). These variants may differ in technical specifications or features, but the core function remains consistent as an interventional fluoroscopic X-ray system. To identify the correct variant, refer to the device’s registration number or consult Philips Medical Systems for compatibility with your procedural needs.

• What regulatory pathway was followed for the Philips Integris Allura, and what does this mean for its use in clinical settings?

  The Philips Integris Allura received FDA 510(k) clearance under classification K002016, indicating it was determined to be substantially equivalent to a legally marketed device. This means it has undergone review by the FDA to ensure safety and effectiveness for its intended use in radiology settings. The clearance confirms it meets regulatory standards for interventional fluoroscopic X-ray systems, allowing its use in clinical practice as described.

• How should the Philips Integris Allura be stored to ensure optimal performance and longevity?

  While the provided data does not specify storage conditions in detail, reusable medical devices like the Philips Integris Allura generally require protection from physical damage, dust, and extreme environmental conditions. Manufacturers typically recommend storing the device in a clean, dry, and controlled environment, following the manufacturer’s guidelines to preserve functionality and ensure compliance with maintenance protocols. Always refer to Philips Medical Systems’ instructions for precise storage recommendations.