Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)

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 Inc.

¿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
    75078
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2886-2016
  • Fecha de inicio del evento
    2016-08-25
  • Fecha de publicación del evento
    2016-09-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149576
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    The firm received multiple reports of xhibit telemetry system going offline or locking up. in addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single canadian hospital.
  • Acción
    Spacelabs sent a letter dated August 25, 2016 to affected US consignees informing them of the going offline or locking up issue when Xhibit Central Station is used as part of an Xhibit Telemetry System. On September 1, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs sent the second Urgent - Medical Device Correction letter, dated September 15, 2016, to affected US consignees informing them that they have received reports of certain short-duration asystole alarms generated by the Xhibit Telemetry Receiver (XTR) where there may be no audible or visual alarm. On September 22, 2016, a second letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to update the recalled Xhibit Telemetry System at no cost. Customers with Xhibit Telemetry Receivers will get all Xhibit Central Stations updated regardless if connected to an Xhibit Telemetry Receiver. Consignees are directed to technical support for additional information or technical assistance: Technical Support Spacelabs Healthcare, Inc 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Device

Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR)
  • Modelo / Serial
    Serial numbers of units distributed in the US   6280-000053, 6280-000056, 6280-000057, 6280-000058, 6280-000059,  6280-000066, 6280-000067, 6280-000068, 6280-000077, 6280-000078,  6280-000079, 6280-000083, 6280-000084, 6280-000085, 6280-000086,  6280-000088, 6280-000090, 6280-000092, 6280-000093, 6280-000095,  6280-000096, 6280-000097, 6280-000098, 6280-000099, 6280-000100,  6280-000101, 6280-000102, 6280-000103, 6280-000104, 6280-000105,  6280-000106, 6280-000107, 6280-000108, 6280-000109, 6280-000110,  6280-000111, 6280-000112, 6280-000113, 6280-000114, 6280-000115,  6280-000116, 6280-000117, 6280-000118, 6280-000120, 6280-000121,  6280-000122, 6280-000123, 6280-000124, 6280-000125, 6280-000126,  6280-000127, 6280-000128, 6280-000129, 6280-000131, 6280-000132,  6280-000137, 6280-000138, 6280-000140, 6280-000141, 6280-000142,  6280-000143, 6280-000146, 6280-000147, 6280-000148, 6280-000149,  6280-000151, 6280-000152, 6280-000153, 6280-000154, 6280-000155,  6280-000156, 6280-000158, 6280-000159, 6280-000160, 6280-000161,  6280-000167, 6280-000168, 6280-000170, 6280-000171, 6280-000172,  6280-000173, 6280-000174, 6280-000176, 6280-000177, 6280-000200,  6280-000228, 6280-000229, 6280-000233, 6280-000234, 6280-000235,  6280-000236, 6280-000238, 6280-000239, 6280-000240, 6280-000241,  6280-000242, 6280-000243, 6280-000245, 6280-000250, 6280-000251,  6280-000252, 6280-000253, 6280-000254, 6280-000255, 6280-000256,  6280-000257, 6280-000260, 6280-000261, 6280-000263, 6280-000264,  6280-000265, 6280-000266, 6280-000267, 6280-000268, 6280-000269,  6280-000271, 6280-000272, 6280-000273, 6280-000274, 6280-000275,  6280-000278, 6280-000279, 6280-000280, 6280-000281, 6280-000283,  6280-000284, 6280-000285, 6280-000286, 6280-000287, 6280-000288,  6280-000289, 6280-000298, 6280-000301, 6280-000302, 6280-000303,  6280-000306, 6280-000307, 6280-000308, 6280-000310, 6280-000311,  6280-000312, 6280-000315, 6280-000316, 6280-000318, 6280-000319,  6280-000321, 6280-000322, 6280-000324, 6280-000326, 6280-000327,  6280-000328, 6280-000329, 6280-000332, 6280-000333, 6280-000334,  6280-000338, 6280-000341, 6280-000342, 6280-000343, 6280-000344,  6280-000345, 6280-000346, 6280-000347, 6280-000348, 6280-000349,  6280-000350, 6280-000351, 6280-000352, 6280-000353, 6280-000354,  6280-000355, 6280-000357, 6280-000358, 6280-000363, 6280-000364,  6280-000365, 6280-000366, 6280-000367, 6280-000368, 6280-000369,  6280-000370, 6280-000375, 6280-000376, 6280-000377, 6280-000378,  6280-000380, 6280-000381, 6280-000382, 6280-000383, 6280-000385,  6280-000386, 6280-000387, 6280-000388, 6280-000389, 6280-000390,  6280-000391, 6280-000392, 6280-000394, 6280-000395, 6280-000396,  6280-000397, 6280-000398, 6280-000399, 6280-000402, 6280-000403,  6280-000404, 6280-000407, 6280-000408, 6280-000409, 6280-000410,  6280-000411, 6280-000412, 6280-000413, 6280-000414, 6280-000415,  6280-000417, 6280-000418, 6280-000419, 6280-000420, 6280-000421,  6280-000423, 6280-000426, 6280-000427, 6280-000429, 6280-000430,  6280-000431, 6280-000432, 6280-000436, 6280-000437, 6280-000438,  6280-000439, 6280-000440, 6280-000455, 6280-000456, 6280-000457,  6280-000458, 6280-000459, 6280-000460, 6280-000461, 6280-000462,  6280-000463, 6280-000464, 6280-000465, 6280-000466, 6280-000467,  6280-000468, 6280-000475, 6280-000476.   Serial numbers of units distributed OUTSIDE the US   6280-000048, 6280-000050, 6280-000052, 6280-000060, 6280-000061,  6280-000062, 6280-000063, 6280-000064, 6280-000065, 6280-000076,  6280-000094, 6280-000178, 6280-000179, 6280-000181, 6280-000182,  6280-000183, 6280-000184, 6280-000185, 6280-000186, 6280-000188,  6280-000190, 6280-000191, 6280-000193, 6280-000194, 6280-000195,  6280-000196, 6280-000197, 6280-000198, 6280-000199, 6280-000202,  6280-000225, 6280-000226, 6280-000231, 6280-000232, 6280-000237,  6280-000246, 6280-000247, 6280-000249, 6280-000262, 6280-000270,  6280-000276, 6280-000282, 6280-000290, 6280-000291, 6280-000292,  6280-000293, 6280-000294, 6280-000295, 6280-000297, 6280-000300,  6280-000305, 6280-000317, 6280-000330, 6280-000331, 6280-000356,  6280-000362, 6280-000371, 6280-000372, 6280-000384, 6280-000400,  6280-000401, 6280-000406, 6280-000416, 6280-000424, 6280-000425,  6280-000433, 6280-000435, and 6280-000473.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
  • Descripción del producto
    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. || Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Dirección del fabricante
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA