Events

Retiro De Equipo (Recall) de Device Recall Hologic Explorer Bone Densitometers

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 Hologic, 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
    48641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2187-2008
  • Fecha de inicio del evento
    2008-06-27
  • Fecha de publicación del evento
    2008-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71782
  • 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
    Bone densitometer - Product Code KGI
  • Causa
    Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
  • Acción
    Hologic notified customers by registered letter titled Urgent: Medical Device Recall, dated 6/27/08, providing instructions to update the software to Version 2.3 and discard version APEX 2.0, 2.1 and 2.2 manuals. If you have questions or require assistance with the software installation, contact Hologic's Help Desk at 1-800-321-4659.

Device

Device Recall Hologic Explorer Bone Densitometers
  • Modelo / Serial
    S/N: 91108 90941 91022 90952 91032 91127 91126 91193 91065 90885 91222 91070 91141 91057 90970 90969 91107 91050 91013 91014 91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049 91151 91152 91153 91154 91155 91213 91214 91215 91218 91238 91239 91240 91241 91242 91243 91253 91254 91256 91257 91262 91263 91265 91266 91268 91269 91051 91099 91165 91100 91143 91054 91012 91039 91076 91258 91224 91260 91261 90920 90924 90934 90938 90923 91028 91029 91031 91026 91030 91113 91114 91128 91180 91186 91187 91183 91210 91212 91226 91208 91227 91229 91252 91034 91205 91281 91111 91211 91202 91228 90939 90945 90953 90971 90972 90942 90976 90995 90996 91009 91033 91036 91060 91071 91072 91068 91069 91059 91105 91106 91118 91123 91124 91133 91137 91138 91181 91182 91221 91223 91225 91259 91283 90911 90978 90994 91066 91103 91104 91125 91250 91064 91075 90988 91174 91271 91109 91110 91132 91135 91184 91094 90954 90955 90956 90957 90958 91097 91098 91101 91102 91136 91146 91147 91148 91149 91150 90977 90984 90985 90986 90987 90997 90998 90999 91001 91002 91003 91007 91008 91052 91053 91055 91077 91078 91079 91080 91085 91086 91087 91157 91158 91159 91198 91199 91168 91169 91170 91171 91172 91093 91167 91173 91176 91177 91234 91235 91236 91179 91237 91244 91245 91264 91275 91276 91277 91278 91279 91207 90992 91006 91063 91084 91119 91161 91232 91246 91255 90982 91142 90993 91062 91083 91120 91121 91122 91130 91145 91160 91162 91163 91164 91196 91247 91248 91273 91274 91185 91190 91027 91156 91280 91203 91042 91081 91082 91131 91233 91061 91021 91000 91004 91267 91067 90990 91134 90937 91140 91197 91175 91091 90981 91117 91178 91209 91251 90940 90980 90983 91035 91115 91144 91231 91092 91249 91270 91272 91010 91011 90979 90991 90989 91025 91056 91058 91088 91089 91090 91095 91096 91112 91116 91139 91188 91192 91194 91189 91204 91191 91195 91230 91206 91005 91040 91200 91201 91216 91217 91219 91220 91166 91037 and 91038
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Foreign: Canada Algeria, AE, Australia, Belgium,China,France, Germany, Hungary, Hong Kong, Iceland, Iran, Ireland, Israel, Italy,Japan,Korea, Kuwait, Lithuania, Mexico, Myanmar, Netherlands, Pakistan, Peru, Russia, S. Africa, Saudi Arabia, Singapore, Slovak Rep., Switzerland, Syria, Taiwan, UK
  • Descripción del producto
    Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
  • Manufacturer
    Hologic, Inc.

Manufacturer

Hologic, Inc.
  • Dirección del fabricante
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • Empresa matriz del fabricante (2017)
    Hologic Inc
  • Source
    USFDA