Events

Recall of Device Recall Allura Xper Philips Xray Systems

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
    79099
  • Event Risk Class
    Class 2
  • Event Number
    Z-0716-2018
  • Event Initiated Date
    2018-01-04
  • Event Date Posted
    2018-02-24
  • 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=161339
  • 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
    There is an increase in the failure rate of certain anode drive units (adu5) used in these products. early life failure of the adus only occurs when the hospital mains provide 480v to the system. this current voltage may lead to saturation and overheating of the coils that protect the igbts (insulated-gate bipolar transistor) of the adu. the overheating may also generate a peculiar burning smell that may be noticed. in some instances this burning smell may be noticed before the adu fails. when the adu fails the x-ray performance of the system is reduced to emergency fluoroscopy. exposure will not be possible and image quality is reduced.
  • Action
    Customer Notification letter dated August 2017 were sent to affected customers. The letter identified affected product, problem and actions to be taken. The customer is requested to place this Field Safety Notice with the documentation of the system until this correction has been implemented. For questions contact your local Philips representative.

Device

Device Recall Allura Xper Philips Xray Systems
  • Model / Serial
    Allura Xper systems - Model #'s 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722078, 722079, (added as of 6/25/2018) 1120
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.
  • Product Description
    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. || Product Usage: || 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 implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties 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