Events

Rappel de Device Recall BrightView XCT BrightView X

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
    68644
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1982-2014
  • Date de mise en oeuvre de l'événement
    2014-06-23
  • Date de publication de l'événement
    2014-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128393
  • 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
    Flat panel display (fpd) failed to remain securely locked in the deployed position.
  • Action
    Philips sent an Field Safety Notice dated June 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice (FSN) 88200490 and Addendum is intended to inform you about the following: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips Healthcare representative: For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts). thcare is informing the consignee of this issue through a Field Safety Notice 88200490. The US consignees will receive this notice via certified mail and Philips Healthcare Key Market representatives will distribute the FSN internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to conduct the appropriate field safety correction through Field Change Order (FCO) 88200490 that will address the above identified issue.

Device

Device Recall BrightView XCT BrightView X
  • Modèle / numéro de série
    BrightView XCT: product code 882482  BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454 All Codes: 6000002,6000004,6000005,6000006,6000010,6000011,6000012,6000013,6000015,6000016, 6000017,6000018,6000019, 600020, 6000021, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027,6000028,6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038,6000040,6000041, 6000042, 6000043, 6000044, 6000045, 6000046, 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, 6000094,6000095,6000096,6000097,6000098,6000099,6000100,6000101, 6000102, 6000103, 6000104,6000105,6000106,6000107,6000108,6000109,6000110,6000111, 6000112, 6000113, 6000114,6000115,6000116,6000117,6000118,6000119,6000120,6000121, 6000122, 6000123, 6000125,6000127,6000128,6000130,6000131,6000132,6000133,6000134, 6000136, 6000139, 6000141,6000142,6000143,6000144,6000146,6000147,6000148,6000149,6000150,6000151, 6000152,6000154,6000155,6000156,6000157,6000158,6000159,6000160,6000161,6000162, 6000163,6000164,6000165,6000166,6000167,6000168,6000169,6000170,6000171,6000172, 6000173,6000174,6000175,6000176,6000177,6000178,6000179,6000180,6000181,6000182, 6000183,6000184,6000185,6000186,6000187,6000188,6000189,6000190,6000191,6000192, 6000193,6000194,6000195,6000197,6000198,6000199,6000200,6000201,6000202,6000203, 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, 6000234,6000235,6000236,6000237,6000238,6000239,6000240,6000241,6000242,6000243, 6000244,6000245,6000246,6000247,6000248,6000249,6000250,6000251,6000252,6000253, 6000254,6000255,6000257,6000258,6000259,6000260,6000261,6000262,6000263,6000264, 6000265,6000266,6000267,6000268,6000269,6000270,6000271,6000272,6000273,6000274, 6000275,6000276,6000277,6000278,6000279,6000280,6000281,6000282,6000283,6000284, 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, 6000325,6000326,6000327,6000329,6000330,6000331,6000332,6000333,6000334,6000335, 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
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
  • Description du dispositif
    BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
  • 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