Events

Recall of Device Recall Philips Medical Allura Xper Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare Inc..

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
    59296
  • Event Risk Class
    Class 2
  • Event Number
    Z-2976-2011
  • Event Initiated Date
    2011-07-08
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102144
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    System freezes from 20 seconds up to one minute. no fluoroscopy exposure and no geometry movements during this time period.
  • Action
    Philips Health Care North America sent a FIELD SAFETY CORRECTION ACTION letter dated July 4, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. This FCD will be identified as FCD72200200 and will be free of charge. This FCD consists a CD with the correct firmware and a installation procedure to implement the FCD correctly. Please contact your local Philips representative. For further follow up please call (978 ) 687-1501.

Device

Device Recall Philips Medical Allura Xper Systems
  • Model / Serial
    Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Allura Xper Systems Models: || Allura Xper FD10 (F/C)-Biplane Fixed || Allura Xper FD10/10 (incl. OR table) || Allura Xper FD20- High resolution fixed-x ray || Allura Xper FD20/10 || Allura Xper FD20/20 || Allura CV20 || The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA