Events

Retiro De Equipo (Recall) de VOLISTA

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 Maquet SAS.

¿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
    79898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1937-2018
  • Fecha de inicio del evento
    2018-04-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163836
  • 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
    Lamp, surgical - Product Code FTD
  • Causa
    Potential keypad failure on volista standop surgical lights.
  • Acción
    The firm, Getting, sent "Urgent Medical Device Recall Notice" letters was issued April 19, 2018 and April 24, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if the device is still in use at the facility via FAX BACK TO: 1-585-486-5605 or EMAIL TO: VOLISTA_StandOP_Keypad_FA.SW-US@getinge.com. The letter instructs the customer to contact Getinge Service to schedule a visit and replacement by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and replace affected control keypads on VOLISTA StandOP lights when identified. Customers with questions may contact Getinge Customer Support at (800) 950-9912 (select option 1). Customer Service hours: 8:00 AM and 5:00 PM (EST) Monday to Friday.

Device

VOLISTA
  • Modelo / Serial
    Serial Numbers: 38013 38016 500641 500644 25002 35025 35028 38012 38015 500000 500001 500003 500004 500014 500015 500016 500018 500037 500039 500020 500060 500063 500642 500643 31053 500058 38009 38026 31002 31030 31048 31054 21001 21002 35024 35012 35013 35014 35015 38017 500001 500017 35029 35017 35027 31019 31020 31022 31024 31025 31026 31000 31000 31001 31002 31003 31006 31009 31010 31012 31008 31047 31050 31051 31052 500002 500060 500061 500072 500073 500680 500685 500686 500687 500692 510082 500062 500064 500042 500044 31012 31013 31014 31020 38011 38014 31006 31008 31015 31016 500068 500070 500071 500074 31021 31023 38018 38019 38020 38021 38022 38023 38024 38025 31004 35011 31004 31017 31018 35000 35001 35018 35019 35020 35021 35022 35023 35026 35030 35031 35032 35033 38027 31001 31003 28003 28004 25005 25006 500055 500059 500011 500013 25007 25004 31039 31040 31041 31042 31043 31044 31045 31046 31055 31056 31005 31009 31011 31017 31019 38025 38026 38027 38028 500065 500066 500067 500069 38000 38002 500002 500005 500010 500012 500056 500059 38001 38003 31031 31049 20502 20503 500075 500076 500609 500610 500611 500612 500613 500614 500615 500616 500617 500618 500619 500620 500066 500067 500068 500069 500070 500071 500072 500073 510007 510008 510009 510010 510011 510012 510013 510014
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, TZ, YE, ZA, ZW).
  • Descripción del producto
    VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL || VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
  • Manufacturer
    Maquet SAS

Manufacturer

Maquet SAS
  • Dirección del fabricante
    Maquet SAS, Parc De Limere, Avenue De La Pomme De Pin, Orleans France
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA