Events

Recall of Device Recall Philips Allura Xper R9 and Azurion R1.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78739
  • Event Risk Class
    Class 2
  • Event Number
    Z-0255-2018
  • Event Initiated Date
    2017-08-18
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160259
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    When using the downscale option with the allura r9 system or azurion r1.1 system, the measurements performed using the qa basic measurement tool will not be correctly exported to the external dicom destination.
  • Action
    Image Guided Therapy Systems ( IGT) sent an Urgent - Field Safety Notice Medical Device Correction letter dated August 11. 2017. The Downscale option should be disabled in all Export protocols until Philips corrects this issue. To accomplish this, you may refer to Chapter 13.8 (Configuring Export Protocols) of the system instructions for use that describes how to perform this action. You may also contact your Philips local representative for assistance in performing this action. All archived images exported using the downscale option would be affected by this issue, therefore such measurements from archived images should not be relied on. Additional precaution could be taken by re-performing measurements during the actual interventional procedure. The problem will be resolved by a software update, which is expected to be available by the end of 2017. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use. For further questions, please call (800) 722-9377.

Device

Device Recall Philips Allura Xper R9 and Azurion R1.1
  • Model / Serial
    7220063, 722064, 22065, 722066, 722078, 722079
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution.
  • Product Description
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA