Events

Rappel de Device Recall BrightView, BrightView X, and 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
    69792
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1011-2015
  • Date de mise en oeuvre de l'événement
    2014-11-12
  • Date de publication de l'événement
    2015-01-26
  • 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=131548
  • 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
    Unintended detector and gantry movement due to software issues.
  • Action
    Philips Healthcare sent an Urgent - Field Safety Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is advising the customers/users to retain a copy of this Field Safety BY CUSTOMER I USER Notice with the equipment Instruction for Use, until further notice. Problem #1: Philips is advising the customer/user to perform the following workaround prior to the implementation of the field safety correction, to avoid contact between the detector and the head holder as describe above in Problem #1: ONLY if the system is positioned in a Relative-90 configuration with one of the detectors below the pallet level and the table in in the patient load position: Follow the sequence of operations prior to performing a study utilizing the head holder: - Deploy or store the x-ray panel if necessary; - Run the patient load PPM; - Install the head holder; and - Position the patient on the table and proceed with the study In addition, take the following preventative actions: " Monitor the patient during any and all system motions. " Know locations of the multiple E-Stop button(s) to halt all system motion. (Emergency Stop: where the system immediately stops all detector and gantry motions by disconnecting power to the motors that control system motion) Customers with questions were instructed to contact the Customer Care Solutions Certer at 1-800-722-9377. For questions regarding this recall call 440-483-2119.

Device

Device Recall BrightView, BrightView X, and BrightView XCT
  • Modèle / numéro de série
    BrightView Model Number 882478; Affected Serial Numbers include: 11000003,11000004,11000005,11000006,11000008,11000009,11000011, 11000012,11000013,11000014,11000015,11000016,11000017,11000018, 11000019,11000020,11000023,11000024,11000025,11000026,11000027, 11000029,11000030,11000031,11000032,11000033,11000034,11000036, 11000037,11000038,11000039,11000040,11000041,11000042,11000043, 11000045,11000046,11000047,11000048,11000049,11000051,11000052, 11000054,11000055,11000056,11000057,11000058,11000059,11000060, 11000061,11000062,11000063,11000064,11000065,11000066,11000068, 11000069,11000071,11000072,11000074,11000075,11000076,11000077, 11000078,11000083,11000085,11000086,11000087,11000089,11000090, 11000091,11000092,11000093,11000094,11000095,11000096,11000097, 11000098,11000099,11000100,11000101,11000102,11000103,11000104, 11000105,11000106,11000107,11000108,11000110,11000111,11000112, 11000113,11000115,11000116,11000117,11000118,11340001,11340002, 11340004, and 11340005.  BrightViewX Model Number 882480; Affected Serial Numbers include: 10422,400054,4000002,4000003,4000004,4000006,4000008, 4000009,4000010,4000011,4000013,4000029,4000030,4000031,4000032, 4000033,4000035,4000036,4000037,4000038,4000039,4000040,4000041, 4000043,4000044,4000046,4000047,4000048,4000051,4000053,4000056, 4000058,4000059,4000060,4000061,4000063,4000064,4000065,4000066, 4000067,4000068,4000070,4000071,4000072,4000073,4000074,4000075, 4000076,4000077,4000078,4000079,4000080,4000081,4000083,4000086, 4000087,4000088,4000089,4000090,4000093,4000094,4000095,4000096, 4000099,4000100,4000102,4000103,4000104,4000105,4000106,4000107, 4000108,4000109,4000111,4000112,4000113,4000114,4000115,4000116, 4000117,4000118,4000120,4000121,4000122,4000123,4000124,4000125, 4000126,4000127,4000128,4000129,4000130,4000132,4000133,4000135, 4000137,4000138,4000139,4000140,4000141,4000142,4000143,4000144, 4000146,4000148,4000149,4000150,4000151,4000152,4000153,4000154, 4000155,4000156,4000157,4000158,4000159,4000160,4000161,4000164, 4000165,4000166,4000167,4000168,4000169,4000170,4000171,4000173, 4000174,4000175,4000176,4000177,4000179,4000180,4000181,4000182, 4000183,4000184,4000185,4000187,4000188,4000189,4000190,4000191, 4000193,4000194,4000195,4000196,4000197,4000198,4000199,4000200, 4000201,4000202,4000204,4000205,4000206,4000207,4000208,4000209, 4000210,4000212,4000214,4000216,4000217,4000218,4000219,4000220, 4000222,4000223,4000224,4000225,4000226,4000227,4000228,4000229, 4000230,4000231,4000232,4000233,4000235,4000236,4000237,4000238, 4000239,4000240,4000241,4000242,4000243,4000244,4000245,4000246, 4000247,4000248,4000249,4000250,4000251,4000252,4000253,4000254, 4000255,4000256,4000257,4000258,4000259,4000260,4000261,4000262, 4000263,4000264,4000265,4000266,4000269,4000270,4000271,4000272, 4000274,4000276,4000277,4000278,4000279,4000280,4000281,4000282, 4000283,4000284,4000285,4000287,4000288,4000289,4000290,4000291, 4000292,4000293,4000295,4000296,4000297,4000298,4000299,4000300, 4000301,4000302,4000303,4000304,4000305,4000306,4000307,4000308, 4000309,4000310,4000311,4000312,4000313,4000314,4000316,4000317, 4000318,4000319,4000320,4000321,4000322,4000323,4000324,4000325, 4000326,4000327,4000328,4000329,4000330,4000331,4000333,4000334, 4000336,4000338,4000339,4000341,4000342,4000344,4000345,4000346, 4000347,4000348,4000352,4000353,4000354,4000355,4000356,4000357, 4000358,4000360,4000361,4000362,4000363,4000364,4000366,4000367, 4000368,4000369,4000370,4000371,4000372,4000374,4000375,4000376, 4000377,4000378,4000379,4000380,4000381,4000382,4000383,4000384, 4000385,4000386,4000387,4000388,4000389,4000390,4000392,4000394, 4000394,4000396,4000397,4000398,4000399,4000400,4000401,4000402, 4000403,4000405,4000406,4000407,4000408,4000410,4000411,4000412, 4000414,4000415,4000416,4000417,4000418,4000419,4000420,4000421, 4000422,4000423,4000424,4000425,4000426,4000428,4000429,4000430, 4000431,4000432,4000433,4000434,4000435,4000437,4000438,4000439, 4000440,4000441,4000442,4000443,4000444,4000445,4000446,4000448, 4000449,4000450,4000451,4000452,4000453,4000454,4000455,4000456, 4000459,4000460,4000461,4000462,4000463,4000464,4000466,4000467, 4000468,4000469,4000470,4000473,4000474,4000475,4000476,4000477, 4000478,4000479,4000480,4000481,4000482,4000483,4000485,4000486, 4000487,4000488,4000489,4000490,4000491,4000492,4000494,4000495, 4000496,4000498,4000499,4000501,4000502,4000503,4000504,4000505, 4000506,4000507,4000508,4000509,4000510,4000511,4000513,4000516, 4000518,4000519,4000520,4000521,4000522,4000523,4000524,4000525, 4000526,4000527,4000528,4000529,4000530,4000531,4000532,4000533, 4000534,4000535,4000536,4000537,4000538,4000539,4000540,4000541, 4000542,4000543,4000544,4000546,4000547,4000549,4000550,4000552, 4000553,4000554,4000555,4000556,4000557,4000558,4000559,4000560, 4000561,4000562,4000563,4000564,4000565,4000566,4000567,4000568, 4000569,4000571,4000572,4000573,4000574,4000575,4000576,4000577, 4000578,4000580,4000581,4000582,4000583,4000584,4000585,4000586, 4000587,4000588,4000589,4000590,4000591,4000592,4000593,4000594, 4000596,4000597,4000598,4000600,4000601,4000602,4000603,4000604, 4000606,4000607,4000608,4000610,4000611,4000612,4000614,4000615, 4000619,4000620,4000621,4000623,4000624,4000625,4000626,4000627, 4000628,4000629,4000630,4000631,4000632,4000633,4000634,4000635, 4000636,4000638,4000639,4000640,4000642,4000643,4000644,4000645, 4000646,4000647,4000649,4000650,4000654,4000655,4000656,4000657, 4000658,4000659,4000660,4000661,4000662,4000663,4000664,4000666, 4000667,4000668,4000669,4000670,4000671,4000672,4000673,4000674, 4000676,4000677,4000678,4000679,4000680,4000681,4000682,4000683, 4000684,4000685,4000686,4000689,4000690, 4000692, 4000693, 4000694, 4340004, 40000092, 40000101, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000472A, 4000484A, and One Unknown.  BrightView XCT Model Numbers 882482 and 882454;  Affected Serial Numbers include: 6000002,6000003,6000004,6000005,6000006,6000010, 6000011,6000012,6000013,6000015,6000016,6000017,6000019,6000020, 6000022,6000023,6000026,6000027,6000028,6000030,6000031,6000032, 6000033,6000036,6000037,6000038,6000039,6000040,6000041,6000042, 6000043,6000044,6000045,6000047,6000048,6000049,6000050,6000051, 6000052,6000053,6000054,6000055,6000056,6000058,6000060,6000061, 6000062,6000063,6000064,6000065,6000066,6000067,6000068,6000069, 6000070,6000071,6000073,6000075,6000076,6000077,6000078,6000079, 6000080,6000081,6000082,6000083,6000084,6000085,6000086,6000087, 6000088,6000089,6000090,6000091,6000092,6000093,6000094,6000095, 6000098,6000099,6000100,6000101,6000102,6000103,6000104,6000105, 6000107,6000108,6000109,6000110,6000111,6000112,6000113,6000114, 6000115,6000116,6000117,6000118,6000119,6000120,6000121,6000122, 6000123,6000125,6000126,6000127,6000128,6000129,6000130,6000131, 6000132,6000133,6000134,6000136,6000138,6000139,6000140,6000141, 6000142,6000143,6000144,6000145,6000146,6000147,6000148,6000149, 6000150,6000151,6000152,6000153,6000154,6000156,6000157,6000158, 6000159,6000160,6000161,6000162,6000163,6000164,6000165,6000166, 6000167,6000168,6000169,6000171,6000172,6000173,6000174,6000175, 6000176,6000177,6000178,6000180,6000181,6000182,6000183,6000184, 6000185,6000186,6000187,6000188,6000189,6000190,6000191,6000192, 6000193,6000194,6000195,6000196,6000197,6000198,6000199,6000200, 6000201,6000202,6000203,6000204,6000205,6000206,6000208,6000209, 6000210,6000211,6000212,6000213,6000214,6000215,6000216,6000218, 6000219,6000220,6000221,6000222,6000223,6000224,6000225,6000226, 6000227,6000228,6000229,6000230,6000231,6000232,6000233,6000234, 6000235,6000236,6000237,6000238,6000239,6000240,6000241,6000242, 6000243,6000244,6000245,6000246,6000247,6000249,6000250,6000251, 6000252,6000253,6000254,6000256,6000257,6000258,6000260,6000262, 6000263,6000264,6000265,6000266,6000267,6000268,6000269,6000270, 6000271,6000273,6000274,6000275,6000276,6000277,6000278,6000279, 6000280,6000281,6000282,6000283,6000284,6000285,6000286,6000287, 6000288,6000290,6000291,6000292,6000293,6000294,6000295,6000296, 6000297,6000298,6000299,6000300,6000301,6000302,6000303,6000305, 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, 6000339,6000340,6000341,6000343,6000344,6000345,6000346,6000348, 6000349,6000350,6000351,6000352,6000353,6000354,6000355,6000356, 6000358,6000359,6000360,6000361,6000362,6000364,6000365,6000366, 6000367,6000368,6000369,6000370,6000371,6000372,6000373,6000374, 6000375,6000376,6000377,6000378,6000379,6000380,6000381,6000382, 6000383,6000384,6000385,6000386,6000387,6000389,6000390,6000391, 6000392,6000393,6000394,6000395,6000396,6000398,6000399,6000400, 6000401,6000402,6000403,6000404,6000407,6000408,6000409,6000410, 6000411,6000413,6000414,6000415,6000416, 6000417, 6000418, 6340008, 6340009, 6340010,11000021, and 6000004A.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United Kingdom, and Viet Nam.
  • Description du dispositif
    BrightView model number: 882478 || BrightView X model number: 882480 || BrightView XCT model number: 882482 and 882454 || 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