Events

Retiro De Equipo (Recall) de Device Recall MDEleva, UDEleva

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 Philips Medical Systems Nederlands.

¿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
    79783
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1606-2018
  • Fecha de inicio del evento
    2018-03-26
  • 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=163436
  • 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, x-ray, stationary - Product Code KPR
  • Causa
    The fixation of the upper and lower tilt actuator, of the md-eleva system might break off and the table will start to rotate from 0 to + 90 i- 90 degree with high speed. this rotating movement cannot be stopped by the user.
  • Acción
    The firm, BU IGT Systems, sent an "URGENT- Field Safety Notice" letter dated 3/23/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the system and call your Philips representative if the following situations occurs: -the table height or tilt movement is not working. - you notice a cracking or snapping sound during system operation. - you experience a blockade in the table height or tilt movement during system movements. -the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. - you have used a CPR stand that obstructed the system, or - you notice any (other) unusual system behavior beyond the normal use of the system. The customers should also avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. In addition, ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. The firm stated: -All possibly affected products in the field will be corrected by means of a field change order free of charge. -A firm representative will replace affected material on the upper and lower tilt actuator in the affected systems. -You will be contacted by our local Philips representative to schedule this corrective action. -This action will start effective April 2018. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722- 9377, 8am to 8pm (EST) Monday thru Friday.

Device

Device Recall MDEleva, UDEleva
  • Modelo / Serial
    System Serial #  201 137 223 228 219 60 272 35 111 85 121 38 120 185 168 32 30 100 235 34 148 149 67 269 191 118 170 241 210 255 8 273 33 240 131 99 193 36 138 96 222 278 257 246 23 147 162 220 47 179 221 126 195 46 144 254 189 75 56 217 83 5 167 6 154 155 156 177 183 157 245 116 62 207 81 113 134 103 115 55 200 180 175 78 93 24 106 110 123 266 3 URF.173 14 202 208 247 225 28 216 262 9 176 261 259 174 114 68 63 122 135 205 224 39 98 80 22 251 142 253 84 181 264 163 73 94 95 160 199 206 159 112 196 151 25 238 150 4 117 50 58 51 79 249 119 204 133 18 13 15 16 17 129 244 227 234 130 31 12 27 11 128 171 237 76 1 143 248 109 42 43 44 172 213 212 2 48 127 19 82 69 70 65 242 54 194 136 190 152 105 233 71 97 132 197 53 211 72 187 209 41 146 125 268 26 77 40
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latvia, Lebanon, Luxembourg, Malaysia, Martinique Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Mutlidiagnost-Eleva with Flat Detector 708034 || As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Dirección del fabricante
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA