Events

Rappel de Device Recall MDEleva, UDEleva

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems Nederlands.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79783
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1607-2018
  • Date de mise en oeuvre de l'événement
    2018-03-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163437
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, stationary - Product Code KPR
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    System Serial # 40 239 123 58 88 172 129 81 136 159 244 238 82 65 249 70 142 188 128 178 117 45 203 79 229 199 126 158 71 60 187 47 197 87 152 105 76 26 124 139 35 15 66 241 150 86 230 22 206 207 222 146 29 151 111 190 59 228 155 4 233 92 30 221 163 201 91 69 44 205 48 18 34 171 110 175 121 174 43 160 185 23 202 209 95 144 50 141 156 708032/14 72 93 98 193 262 189 118 218 153 33 104 53 216 177 116 38 64 196 49 181 37 180 164 240 135 183 17 125 170 54 NL73 113 90 24 6 27 42 73 246 133 84 214 83 192 149 169 62 61 191 195 100 227 236 97 99 101 102 46 219 103 226 173 89 140 2 36 20 80 32 161 5 51 94 12 176 212 179 25 96 39 154 63 182 157 85 200 234 19 132 21 165 13 120 41 10 56 55 3 7 8 106 114 108 213 14 115 107 31 112
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    MultiDiagnostic-Eleva with Flat Detector 708038 || 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
  • Adresse du fabricant
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA