Device Recall ALLURA XPER FD20/10

  • Modèle / numéro de série
    Site numbers: 41445615, 41445628, 42479274, 42508759, 43315510, 43436747, 43443622, and 43635004.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Allura XPER FD20/10
  • Manufacturer