Events

Retiro De Equipo (Recall) de Device Recall Integrated Module Housing

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare, Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63007
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2382-2012
  • Fecha de inicio del evento
    2012-08-27
  • Fecha de publicación del evento
    2012-09-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112262
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    There is a potential failure of the integrated module housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
  • Acción
    Spacelabs Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-522-7025 and select 2 for assistance regarding this recall.

Device

Device Recall Integrated Module Housing
  • Modelo / Serial
    Domestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408.   International - 1493-002941, 1493-003666, 1493-003689, 1493-003690, 1493-003691, 1493-003692, 1493-003910, 1493-003911, 1493-003912, 1493-003913, 1493-003946, 1493-003947, 1493-003948, 1493-003949, 1493-003950, 1493-003951, 1493-003952, 1493-003953, 1493-003954, 1493-003955, 1493-003956, 1493-003966, 1493-003967, 1493-003968, 1493-003969, 1493-003970, 1493-003971, 1493-003972, 1493-003973, 1493-003974, 1493-003975, 1493-003976, 1493-003977, 1493-003978, 1493-003979, 1493-003980, 1493-003981, 1493-003982, 1493-003983, 1493-003984, 1493-003986, 1493-003987, 1493-003988, 1493-003989, 1493-003990, 1493-003991, 1493-003992, 1493-003993, 1493-003994, 1493-003995, 1493-003996, 1493-003997, 1493-003998, 1493-003999, 1493-004000, 1493-004001, 1493-004002, 1493-004003, 1493-004004, 1493-004005, 1493-004008, 1493-004009, 1493-004010, 1493-004012, 1493-004013, 1493-004014, 1493-004015, 1493-004016, 1493-004017, 1493-004018, 1493-004019, 1493-004020, 1493-004021, 1493-004022, 1493-004024, 1493-004025, 1493-004035, 1493-004036, 1493-004037, 1493-004038, 1493-004039, 1493-004040, 1493-004041, 1493-004042, 1493-004045, 1493-004046, 1493-004065, 1493-004066, 1493-004072, 1493-004073, 1493-004074, 1493-004076, 1493-004078, 1493-004079, 1493-004080, 1493-004081, 1493-004083, 1493-004087, 1493-004088, 1493-004089, 1493-004090, 1493-004091, 1493-004092, 1493-004093, 1493-004094, 1493-004095, 1493-004096, 1493-004097, 1493-004098, 1493-004099, 1493-004100, 1493-004101, 1493-004102, 1493-004103, 1493-004104, 1493-004105, 1493-004107, 1493-004108, 1493-004109, 1493-004110, 1493-004111, 1493-004129, 1493-004131, 1493-004132, 1493-004133, 1493-004134, 1493-004135, 1493-004136, 1493-004137, 1493-004138, 1493-004139, 1493-004140, 1493-004141, 1493-004142, 1493-004143, 1493-004144, 1493-004145, 1493-004146, 1493-004147, 1493-004148, 1493-004149, 1493-004150, 1493-004151, 1493-004152, 1493-004153, 1493-004154, 1493-004155, 1493-004165, 1493-004166, 1493-004167, 1493-004168, 1493-004169, 1493-004170, 1493-004171, 1493-004186, 1493-004187, 1493-004188, 1493-004189, 1493-004190, 1493-004191, 1493-004192, 1493-004193, 1493-004194, 1493-004195, 1493-004196, 1493-004197, 1493-004198, 1493-004199, 1493-004200, 1493-004201, 1493-004202, 1493-004203, 1493-004204, 1493-004300, 1493-004304, 1493-004305, and 670-1350-00.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Ultraview SL 91493 Integrated Module Housing. || PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA