Events

Recall of Device Recall Allura Xper R8.x.25.5 (only with a FlexVision large screen monitor)

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
    79770
  • Event Risk Class
    Class 2
  • Event Number
    Z-1589-2018
  • Event Initiated Date
    2018-03-14
  • 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=163417
  • 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
    After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
  • Action
    Field Safety Notices were distributed on 3/14/18. The notices instructed customers: To prevent occurrence of the issue customers shall restart the system at least once a day. Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The problems will be resolved by a software update, which is expected to be available by the second half of 2018. You will be notified by your local Philips representative when the software update is available for installation. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377, 8am to 8pm (EST) Monday thru Friday.

Device

Device Recall Allura Xper R8.x.25.5 (only with a FlexVision large screen monitor)
  • Model / Serial
    Product name: Allura Xper R8.1 .25.0  Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5  Product code: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 7322039, 722058, 722059.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
  • Product Description
    Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system || Product Usage: || The Allura Xper ED 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, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room.
  • 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