Rappel de Device Recall Philips Ingenuity Core 128

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75756
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0696-2017
  • Date de mise en oeuvre de l'événement
    2016-11-12
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    Software error due to the filament on timer.
  • Action
    Philips sent a Customer Information Letter dated November 14, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

Device

  • Modèle / numéro de série
    30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32172,  52023, 52028, 52049, 52073, 320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211, 320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320253, 320254, 320255, 320256, 320257, 320258, 320260, 320261, 320262, 320263, 320264, 320265, 320266, 320267, 320268, 320269, 320270, 320271, 320272, 320273, 320274, 320275, 320276, 320277, 320278, 320279, 320280, 320282, 320283, 320284, 320286, 320287, 320294, 320298, 320301, 320307, 320310, 320311, 320312, 320313, 320330, 320334, 320336, 320338, 320339, 320340, 320341, 320343, 336011, 336012, 336013, 336015, 336016, 336017, 336018, 336023, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336046, 336051, 336059, 336060, 336064, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336073, 336075, 336076, 336077, 336078, 336079, 336080, 336081, 336082, 336083, 336085, 336086, 336087, 336088, 336089, 336090, 336091, 336092, 336093, 336094, 336095, 336096, 336097, 336098, 336099, 336100, 336101, 336102, 336103, 336104, 336105, 336106, 336107, 336108, 336109, 336110, 336111, 336112, 336113, 336114, 336115, 336116, 336117, 336118, 336119, 336120, 336122, 336123, 336124, 336125, 336126, 336127, 336128, 336129, 336130, 336131, 336132, 336133, 336134, 336135, 336136, 336137, 336138, 336139, 336140, 336141, 336142, 336143, 336144, 336145, 336146, 336147, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336165, 336166, 336167, 336168, 336169, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336179, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336187, 336188, 336189, 336190, 336191, 336192, 336193, 336194, 336195, 336196, 336197, 336198, 336199, 336200, 336201, 336202, 336203, 336204, 336205, 336206, 336207, 336208, 336209, 336210, 336211, 336212, 336213, 336214, 336215, 336216, 336217, 336220, 336221, 336223, 336224, 336225, 336226, 336227, 336228, 336230, 336231, 336232, 336233, 336235, 336243, 336245, 336247, 336248, 336257, 336259, 336260, 336261, 336262, 336263,  336265, 336267, 336268, 336269, 336270, 336271, 336272 and 336273.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
  • Description du dispositif
    Ingenuity Core 128 728323
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
  • Source
    USFDA