Devices

Device Recall Allura Xper FD20/10

  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
  • Product Description
    Allura Xper FD20/10; Model Numbers: 722029 || 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. " Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
  • Manufacturer
    Philips Electronics North America Corporation
  • 1 Event

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

2 devices with a similar name

Learn more about the data here

Device Recall Allura XPER FD20/10
  • Model / Serial
    FCO 72200122 and 72200123 for the 1st phase 72200133 for the 2nd phase Equipment #'s  548432, 549242, 555356, 41443586, 41443727, 41443765, 41443909, 41444645, 41444752, 41444816, 41455925, 41455953, 42046093, 41445118 547914, 552599, 41455933, 504674, 534156, 538095, 538099, 538481, 539213, 540461, 541276, 542963, 543690, 543953, 544306, 544543, 544635, 544656, 544668, 544844, 545518, 545583, 545882, 546119, 546149, 546906, 547215, 547431, 547642, 547715, 548005, 548020, 548036, 548082, 548383, 548618, 549202, 549370, 550198, 550691, 550758, 550812, 550935, 552355, 552639, 553685, 553699, 553766, 558604, and 41444689.  Additional Equipment #s from Phase 2 - 85130, 85634, 86450, 86584, 86985, 87317, 87359, 100812, 102908, 102937, 102974, 103381, 103722, 104341, 558945, 41443627, 41445615, 41445628, 41446230, 41446773, 41455944, 41793290, 41796154, 42067824, 42479274, 42508759, 42735090, 42891020, 42891095, 43058934, 43315510, 43436747, 43443622, 43635004, 43670742, 44616211, and 44735751.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Allura XPER FD20/10
  • Manufacturer
    Philips Medical Systems North America Co. Phillips
Device Recall ALLURA XPER FD20/10
  • Model / Serial
    Site numbers: 41445615, 41445628, 42479274, 42508759, 43315510, 43436747, 43443622, and 43635004.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
  • Product Description
    ALLURA XPER FD20/10 || The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips