Events

Retiro De Equipo (Recall) de Device Recall Syngo Dynamics

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 Siemens Medical Solutions USA, 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
    73479
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1183-2016
  • Fecha de inicio del evento
    2016-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144270
  • 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
    System, image processing, radiological - Product Code LLZ
  • Causa
    Siemens' conducting a recall due to a potential issue when using the measurement package of the va10 version of syngo dynamics.
  • Acción
    The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2016 to customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions provided on what steps the user can take to avoid the issue and to forward the notice to the new owner, if you sold this device/equipment and its no longer in your possession. Siemens is preparing a modification of syngo Dynamics that will resolve this potential malfunction. If you have any question, contact Regulatory Technician Specialist at 610-448-6478 or email: Anastasia.sokolova@siemens.com.

Device

Device Recall Syngo Dynamics
  • Modelo / Serial
    Serial #:  85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.
  • Descripción del producto
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 || intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA