Events

Recall of Device Recall Alsius CoolGard Temperature Regulation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alsius Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34073
  • Event Risk Class
    Class 3
  • Event Number
    Z-0369-06
  • Event Initiated Date
    2005-11-09
  • Event Date Posted
    2006-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43073
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, Hypothermia, Intravenous, Cooling - Product Code NCX
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Alsius CoolGard Temperature Regulation System
  • Manufacturer
    Alsius Corporation

Manufacturer

Alsius Corporation
  • Manufacturer Address
    Alsius Corporation, 15770 Laguna Canyon Rd Ste 150, Irvine CA 92618-3111
  • Source
    USFDA