Events

Retiro De Equipo (Recall) de Device Recall GlideScope Video Laryngoscope (AVL)

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 Verathon, 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
    72642
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0421-2016
  • Fecha de inicio del evento
    2015-11-30
  • Fecha de publicación del evento
    2015-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141767
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Causa
    Certain models and serial numbers of glidescope gvl and avl laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. the potential for blade separation may not be readily visible during routine inspection before or after intubation.
  • Acción
    The Urgent Medical Device Recall letter, dated November 30, 2015, had an error on the dates of manufacture for the AVL devices. Once Verathon discovered the incorrect information, the notification letter was revised and it was sent on December 7, 2015 to any customers that received the previous letter between 11/30/15 and 12/2/15. **************************************************************************************** Verathon sent an Urgent Medical Device Recall letter dated November 30, 2015, to all affected consignees. Verathon will, at no cost to you, test your GlideScope GVL and/or AVL blades that fall within the serial number ranges identified to determine whether the blades exhibit the defect that may result in separation of the blade. For all blades that we determine to exhibit this defect, Verathon will replace the blade, free of charge, with a blade of the same model and size. If the blade passes the testing without any evidence of the defect, we will return it to you in its current condition. Please note that this testing will not return blades to their original, factory condition. Verathon will provide you with a loaner blade for each blade in your possession that is subject to this recall, so you will not experience any interruption in use of your GlideScope system. To comply with this recall notice for the affected models and serial numbers of GlideScope GVL and A VL blades, please take the following actions: " Fill out the attached Recall Response Form and return it to Verathon by fax, (425) 883-2896, or email, CSNotifications@verathon.com . Please return the form even if you do not have any blades subject to the recall. " Contact Customer Care to arrange for delivery of a loaner blade and return of your recalled blade. Customer Care will issue you an "RMA" number and arrange for shipment of a loaner blade. Do not send us your current blade(s) until you receive the loaner blade(s). Should you have any questions about th

Device

Device Recall GlideScope Video Laryngoscope (AVL)
  • Modelo / Serial
    ***ADDITIONAL 23 SERIAL NUMBERS IN US AND INTERNATIONAL AS OF 12/31/15***  AD145054, AD151509, AD151510, AD151511, AD151512, AD151514, AD151516, AD151517, AD151518, AD151519, AD151520, AD151521, AD151522, AD151523, AD151526, AE151507, AE151529, AE151542, AE151543, AE151544, AF151517, AF151518, and AF151522.   ****SERIAL NUMBERS OF UNITS IN THE US***************************************** AD141605, AD141610, AD141614, AD141615, AD141618, AD141621, AD141622, AD141623, AD141624, AD141646, AD141647, AD141651, AD141652, AD141653, AD141654, AD141655, AD141674, AD141684, AD145000, AD145001, AD145005, AD145006, AD145007, AD145008, AD145010, AD145011, AD145012, AD145013, AD145014, AD145015, AD145027, AD145028, AD145029, AD145030, AD145031, AD145035, AD145036, AD145037, AD145040, AD145041, AD145042, AD145043, AD145044, AD145045, AD145046, AD145047, AD145048, AD145050, AD145051, AD145052, AD145057, AD145064, AD145065, AD145066, AD145069, AD151504, AD151505, AD151535, AE141629, AE141631, AE141632, AE141633, AE141638, AE141639, AE141640, AE145011, AE145012, AE145013, AE145014, AE145015, AE145016, AE145017, AE145018, AE145019, AE145020, AE145021, AE145022, AE145023, AE145026, AE145027, AE145028, AE145032, AE145033, AE145034, AE145035, AE145036, AE145037, AE145038, AE145039, AE145040, AE146010, AE146011, AE146012, AE146013, AE146014, AE146015, AE146016, AE146017, AE146018, AE146019, AE146020, AE146021, AE146022, AE146023, AE146024, AE146025, AE146026, AE146027, AE146033, AE146034, AE146035, AE146036, AE146037, AE146038, AE146039, AE146040, AE146041, AE146042, AE146043, AE146047, AE146048, AE146051, AE146053, AE146054, AE151504, AE151505, AE151506, AE151513, AE151514, AE151515, AE151516, AE151517, AE151518, AE151519, AE151520, AE151522, AE151523, AE151524, AE151525, AE151526, AE151535, AE151538, AE151539, AE151540, AE151541, AF141570, AF141571, AF141580, AF141582, AF145006, AF145011, AF145015, AF146019, AF146029, AF146031, AF146032, AF146035, AF146036, AF146037, AF146038, AF151500, AF151502, AF151503, AF151504, AF151505, AF151506, AF151508, AF151510, AF151512, AF151515, and AF151516.   ****SERIAL NUMBERS OF UNITS OUTSIDE THE US**************** AD141603, AD141604, AD141607, AD141608, AD141609, AD141611, AD141612, AD141613, AD141617, AD141619, AD141620, AD141625, AD141626, AD141627, AD141628, AD141629, AD141631, AD141632, AD141633, AD141634, AD141635, AD141636, AD141637, AD141638, AD141639, AD141640, AD141641, AD141642, AD141643, AD141644, AD141645, AD141648, AD141650, AD141656, AD141657, AD141658, AD141659, AD141660, AD141661, AD141662, AD141663, AD141664, AD141665, AD141666, AD141667, AD141668, AD141669, AD141670, AD141671, AD141672, AD141673, AD141675, AD141676, AD141677, AD141678, AD141679, AD141680, AD141681, AD141682, AD141683, AD145002, AD145003, AD145016, AD145017, AD145018, AD145019, AD145020, AD145021, AD145022, AD145023, AD145024, AD145025, AD145026, AD145032, AD145033, AD145034, AD145038, AD145039, AD145049, AD145053, AD145055, AD145056, AD145058, AD145059, AD145060, AD145061, AD145062, AD145063, AD145068, AD145070, AD145071, AD145072, AD146000, AD146002, AD146003, AD146004, AD146005, AD146006, AD146007, AD146008, AD146009, AD146010, AD146011, AD146012, AD146013, AD146014, AD146015, AD151500, AD151501, AD151502, AD151503, AD151506, AD151507, AD151508, AE141630, AE141634, AE141635, AE141636, AE141637, AE141641, AE141642, AE141643, AE141644, AE141645, AE141646, AE141647, AE141648, AE141649, AE141650, AE141652, AE141653, AE141654, AE141655, AE141656, AE141657, AE141664, AE141665, AE141666, AE141667, AE141668, AE141669, AE145000, AE145001, AE145002, AE145003, AE145004, AE145005, AE145006, AE145007, AE145008, AE145009, AE145025, AE145029, AE145030, ae145031, AE146000, AE146001, AE146003, AE146004, AE146006, AE146007, AE146008, AE146009, AE146028, AE146029, AE146031, AE146032, AE146044, AE146045, AE146046, AE146052, AE151500, AE151501, AE151502, AE151503, AE151508, AE151509, AE151510, AE151511, AE151512, AE151521, AE151527, AE151528, AE151532, AE151533, AE151534, AE151536, AE151537, AE151545, AF141572, AF141573, AF141579, AF141581, AF141583, AF141585, AF141586, AF141587, AF141588, AF141589, AF145000, AF145001, AF145002, AF145003, AF145005, AF145007, AF145008, AF145009, AF145010, AF145013, AF145014, AF145016, AF145017, AF145018, AF145019, AF145020, AF145021, AF146000, AF146001, AF146002, AF146003, AF146004, AF146005, AF146006, AF146007, AF146008, AF146009, AF146010, AF146011, AF146012, AF146013, AF146014, AF146015, AF146016, AF146017, AF146018, AF146020, AF146021, AF146022, AF146023, AF146024, AF146025, AF146026, AF146027, AF146028, AF146030, AF146033, AF146034, AF151501, AF151507, AF151513, AF151514, AF151520, AF151521, and AF151525.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide including Puerto Rico) and Internationally to Bahrain, Belgium, Bermuda, Brunei Darussalam, Bulgaria, Canada, China , Czech Republic, Denmark, France, Georgia, Germany, Greece, India , Indonesia, Iran , Israel, Italy , Japan, Kuwait, Lebanon, Malaysia, Morocco, Palestinian Territories, Panama, Peru, Philippines, Republic of Serbia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, and U.A.E.
  • Descripción del producto
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. || AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Dirección del fabricante
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA