Events

Rappel de Device Recall BrightView XCT & BrightView XCT

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
    73010
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1022-2016
  • Date de mise en oeuvre de l'événement
    2015-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143039
  • 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, tomography, computed, emission - Product Code KPS
  • Cause
    The firm discovered four issues with the brightview family systems. issue 1: during a cardiac non-auto body contouring (abc) scan, using cardiac high resolution (chr) collimators, the collimator may come in contact with the bottom edge of the patient pallet. if this occurs, collision sensors would pause the scan. issue 2: during a scan, the gantry motion may halt prematurely. this cause.
  • Action
    On 12/22/2015, the firm sent Customer Information Letters to their consignees. The letter identified the product, problem and actions to be taken by the customers.

Device

Device Recall BrightView XCT & BrightView XCT
  • Modèle / numéro de série
    Model #: 882482; Serial #'s: 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000068, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000075, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000112, 6000113, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000207, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000261, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271, 6000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000289, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000301, 6000302, 6000303, 6000304, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000340, 6000341, 6000342, 6000343, 6000344, 6000345, 6000346, 6000347, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000363, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000374, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000391, 6000392, 6000393, 6000394, 6000395, 6000396, 6000398, 6000399, 6000400, 6000401, 6000402, 6000403, 6000404, 6000405, 6000406, 6000407, 6000408, 6000409, 6000410, 6000411, 6000412, 6000413, 6000414, 6000415, 6000416, 6000417, 6000418, 6000419, 6000420, 6000421, 6000422, 6000423, 6000424, 6000425, 6000426, 6000427, 6000428, 6340008, 6340009, 6340010, 6340011, 6000004A, 6000014, 6000039, 6000046, 6000082, 6000163, 6000243, 6000282 & 6000006A.  XCT Upgrade Model #: 882454; Serial #'s: 11000021, 11000082 & 11000111.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.
  • Description du dispositif
    BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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