Events

Retiro De Equipo (Recall) de Thermo Scientific Microm

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 Richard-Allan Scientific Company.

¿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
    59316
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0039-2012
  • Fecha de inicio del evento
    2011-08-12
  • Fecha de publicación del evento
    2011-10-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102246
  • 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
    Microtome, Rotary - Product Code IDO
  • Causa
    The firm has received two complaints of finger lacerations in operators of this device.
  • Acción
    ThermoFisher Scientific sent "URGENT MEDICAL DEVICE CORRECTION, RE: Thermo Scientific HM355S-3 User Safety Advisory Notice" to all affected customers. The letter states the manufacturer identified a need to enhance the safety instructions and the description of the safety devices in the user manual. It mentions the HM3555S-3 User Manual has been modified to include more specific safe work practices and a new Quick -Reference Card summarizing the manual's safety enhancements and that the changes have been included on a CD that is enclosed with the letter. The firm requests confirmation of receipt of the new User Manual and Quick-Reference Card by October 31, 2011 to be sent by FAX to (269) 372-2674 For questions on this recall call the firms Technical Support representatives at 1-800-522-7270 08:00 AM- 4:30 PM.

Device

Thermo Scientific Microm
  • Modelo / Serial
    Model HM355S-3, Serial Nos: 34450, 34519, 34520, 34601, 34662, 34665, 34807, 34922, 35030, 35032, 35033, 35159, 35637, 35793, 35976, 35978, 35978, 38337, 38584, 38651, 39238, 39280, 39281, 39542, 39795, 40607, 41039, 45104, 45367, 45369, 45371, 45760, 45845, 47466, 47467, 47468, 47469, 47772, 47773, 47774, 47775, 47776, 48095, 48096, 48097, 48098, 48109, 48110, 48111, 48112, 48113, 48114, 48115, 48116, 48184, 48252, 48253, 48254, 48259, 48260, 48261, 48314, 48315, 48593, 48594, 48910, 48911, 48912, 48913, 48914, 48915, 48916, 48917, 48918, 48919, 48920, 48921, 48922, 48923, 48924, 48978, 48978, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49209, 49209, 49210, 49210, 49211, 49211, 49212, 49213, 49213, 49214, 49214, 49221, 49223, 49230, 49286, 49287, 49288, 49289, 49290, 49291, 49292, 49293, 49294, 49295, 49296, 49297, 49298, 49299, 49300, 49301, 49302, 49303, 49304, 49305, 49306, 49307, 49308, 49309, 49310, 49311, 49312, 49962, 49963, 49964, 49965, 49966, 49967, 49968, 49969, 49970, 49971, 49972, 49973, 49974, 49975, 49976, 49977, 49978, 49989, 49990, 49991, 49992, 49993, 49994, 49995, 50221, 50222, 50224, 50225, 50226, 50578, 50579, 50580, 50581, 50582, 50583, 50584, 50585, 50586, 50587, 50676, 50677, 50678, 50679, 50680, 50681, 50791, 50792, 50793, 50794 and 50911.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Nationwide distribution; including the country of Canada.
  • Descripción del producto
    Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 || Used for slicing tissue blocks.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • Dirección del fabricante
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA