Device Recall DigitalDiagnost Xray system

  • Modèle / numéro de série
    119 units are identified with Site Numbers:  59667, 82641, 82681, 86222, 86987, 86988, 103893, 103894, 104465, 104937, 104938, 105367, 504989, 505545, 506776, 532141, 536043, 536913, 539410, 540477, 540996, 541079, 541086, 541856, 541857, 542605, 542606, 543430, 544119, 544135, 544487, 544632, 544634, 544658, 545606, 547799, 548185, 548186, 548245, 548391, 548392, 548670, 549294, 549418, 549428, 549651, 549876, 549877, 549912, 550016, 550021, 550071, 550229, 550262, 550271, 550343, 550352, 550357, 550359, 550361, 550362, 550363, 550414, 550415, 550417, 550418, 550547, 550828, 550846, 550874, 550878, 550891, 550937, 551006, 551022, 551574, 551668, 551673, 552375, 552378, 552380, 552404, 552457, 552641, 553014, 553272, 553273, 553421, 553424, 553573, 553607, 554063, 554335, 554354, 554359, 554422, 554449, 554517, 554711, 554714, 554771, 555163, 555164, 555534, 555685, 555754, 553017, 531994, 535549, 543218, 543847, 547216, 549742, 550312, 551522, 552507, 552876, 552914, and 555119.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: including the states of AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI.
  • Description du dispositif
    DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. || The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.
  • Manufacturer
  • 1 Event

Fabricant

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