Events

Rappel de Device Recall Alsius CoolGard Temperature Regulation System

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 Alsius Corporation.

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
    34073
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0369-06
  • Date de mise en oeuvre de l'événement
    2005-11-09
  • Date de publication de l'événement
    2006-01-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43073
  • 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, Hypothermia, Intravenous, Cooling - Product Code NCX
  • Cause
    Alsius has found that fluid spills or ingress may result in an alarm condition. the potential health risk involved in this state can be the discontinuance of therapy.
  • Action
    Alsius Corporation is notifying customers of an issue requiring service of their CoolGard 3000 by letter shipped via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt.

Device

Device Recall Alsius CoolGard Temperature Regulation System
  • Modèle / numéro de série
    Serial # 30000011 30000012 30000013 30000014 30000016 30000017 30000018 30000019 30000020 30000022 30000023 30000024 30000025 30000026 30000027 30000029 30000030 30000031 30000032 30000033 30000034 30000035 30000036 30000037 30000038 30000039 30000040 30000041 30000042 30000043 30000044 30000045 30000046 30000047 30000048 30000049 30000050 30000051 30000052 30000053 30000054 30000055 30000056 30000057 30000058 30000059 30000060 30000061 30000062 30000063 30000064 30000065 30000066 30000068 30000069 30000070 30000071 30000072 30000073 30000074 30000075 30000076 30000077 30000078 30000079 30000081 30000082 30000083 30000084 30000085 30000086 30000087 30000088 30000089 30000090 30000091 30000092 30000093 30000094 30000095 30000096 30000097 30000098 30000100 30000101 30000102 30000103 30000104 30000105 30000106 30000107 30000108 30000109 30000110 30000111 30000112 30000113 30000114 30000115 30000116 30000117 30000118 30000119 30000120 30000121 30000122 30000123 30000124 30000125 30000126 30000127 30000128 30000129 30000130 30000131 30000132 30000133 30000134 30000136 30000138 30000139 30000140 30000141 30000142 30000143 30000144 30000145 30000146 30000147 30000148 30000149 30000150 30000151 30000152 30000154 30000155 30000156 30000157 30000158 30000159 30000160 30000162 30000163 30000164 30000165 30000166 30000167 30000168 30000169 30000170 30000171 30000172 30000173 30000174 30000175 30000176 30000177 30000178 30000179 30000180 30000181 30000182 30000183 30000184 30000185 30000186 30000187 30000188 30000189 30000190 30000191 30000192 30000193 30000194 30000195 30000196 30000197 30000198 30000199 30000200 30000201 30000202 30000203 30000204 30000205 30000206 30000207 30000208 30000209 30000210 30000211 30000212 30000213 30000214 30000215 30000216 30000217 30000218 30000219 30000220 30000221 30000222 30000223 30000224 30000225 30000226 30000227 30000228 30000229 30000230 30000232 30000233 30000234 30000235 30000236 30000237 30000238 30000239 30000240 30000241 30000242 30000243 30000244 30000245 30000246 30000247 30000248 30000249
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom
  • Description du dispositif
    Alsius CoolGard Temperature Regulation System
  • Manufacturer
    Alsius Corporation

Manufacturer

Alsius Corporation
  • Adresse du fabricant
    Alsius Corporation, 15770 Laguna Canyon Rd Ste 150, Irvine CA 92618-3111
  • Source
    USFDA