Events

Rappel de C300 Consumer Ceiling Lift

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 ErgoSafe Products, LLC (DBA) Prism Medical.

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
    71680
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0284-2016
  • Date de mise en oeuvre de l'événement
    2015-09-08
  • Date de publication de l'événement
    2015-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138726
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Cause
    Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use.
  • Action
    The firm, Prism Medical, sent a "Field Safety Notice (FSN 0008)" letter dated 9/8/2015 to all consignees by email via their sales portal. The letter describes the product, problem and actions to be taken. The consignees were instructed to call Prism Medical directly at 1-314-219-8655 and indicate that you are participating in the 300 series lift recall; provide your existing 300 series lift model number and serial number; follow the instructions provided; complete and return the Acknowledgement Form via scanned & signed to bschoenman@prismmedicalltd.com or fax to: 314-692-7858, Attention: 300 series recall. For further information please contact: Prism Medical Quality department at: 1-314-219-8655 or North American Director for Quality & Regulatory Affairs at 1-314-219-8614.

Device

C300 Consumer Ceiling Lift
  • Modèle / numéro de série
    All serial numbers produced since October 2011. Part 330050: SN C303094 C303510 C303374 C303922 C303924 C303925 C303257 C303386 C303223 C303264 C303492 C303239 C303352 C303326 C304076 C303429 C303847 C303457 C303065 303333 C303095 C303136 C303149 C303158 C303190 C303194 C303168 C304108 C303481 C303907 C303430 C303349 C303301 C303302 C303195 C303378 C303897 C303271 C303159 C303362 C303234 C303058 C303068 C304082 C303392 C303895 C303900 C303341 C303060 C303235 C303023 p303952 C303024 C303005 C303057 C303086 C303090 C303092 C303118 C303138 C303140 C303141 C303142 C303152 C303154 C303155 C303161 C303163 C303191 C303192 DEMOC002 DEMOC010 C303025 C303026 C303196 C303238 C303241 C303245 C303021 C303067 C303391 C303143 C303153 C303226 C303304 C303385 C303495 C303393 C303432 C303237 C303476 C303323 C303361 C303363 C303366 C303389 C303321 C303344 C303943 C304057 C303381 C303419 C303451 C303263 C303282 C303348 C303244 C303431 C303270 C303220 C303242 C303164 C303036 C303044 C303047 C303049 C303052 C303054 C303483 C303909 C303908 C303951 C304054 C303434 C303453 P303415 C303249 C303250 C303251 C303252 C303256 C303474 C303268 C303420 C303435 C303494 C303902 C303340 C303266 C303300 C303412 C303479 C303477 C303390 C303493 C303262 C303334 C303351 C303472 C303069 C303145 C303303 C303322 C303894 C303911 C303923 C303414 C303421 C303422 C303424 C303452 C303454 C303464 C303490 C303491 C303845 C303901 C303905 C303913 C303914 C303916 C303917 C303918 C303920 C303921 C303946 C303948 C303949 C303970 C304055 C304056 C304079 C303945 303283 C303346 C303411 C303953 C303915 C303265 C303267 C303458 C303471 C303465 C303416 C303329 C303066 C303156 C303253 C303254 C303280 C303281 C303327 C303387 C303317 C303473 C303427 C303470 C303064 C303150 C303221 C303224 C303384 C303388 C303850 C303489 C303260 C303342 C303365 C303947 C304075 C304081 C303425 C303840 C303841 C303842 C303843 C303844 C303888 C303892 C303956 C303160 DEMOC006 C303345 C303062 C303130 C303318 C303478 C303382 C303353 C303373 C303418 C303157 C303236 C303898 C303413 C303456 C303462 C303463 C303904 C303906 C304080 C303269 C303417 303330 C303433 C303426 C303952 C303350 C303147 C303423 C303846 C303450 C303243 C303167 C303027 C303050 C303059 C303061 C303085 C303087 C303088 C303089 C303091 C303093 C303095 C303096 C303097 C303114 C303115 C303116 C303117 C303137 C303139 C303144 C303146 C303148 C303151 C303162 C303189 C303193 C303194 C303848 C303849 C303896 C303899 C303142 000014 00010 00011 00012 00013 303163 C303001 C303003 C303038 C303055 C303163 C303222 C303227 C303240 C303246 C303247 C303944 C303955 C303028 C303030 C303031 C303032 C303035 C303037 C303039 C303040 C303041 C303042 C303045 C303048 C303063 C303086 C303140 C303169 C303192 C303903 C303912 C303033 C303057 C303090 C303092 C303138 DEMOC013 C303029 C303034 C303046 C303053 C303331 C303161 Part: 330050R: SN C303071 C303461 C303259 C303460 Part 330053: SN CQ303310 CQ303293 CQ303360 C303127 CQ303209 CQ303118 CQ303119 CQ303120 CQ303142 CQ303223 CQ303276 PUQHS003920 CQ303122 CQ303136 CQ303212 C303230 CQ303157 CQ303284 C303077 C303080 C303102 C303134 C303172 C303214 CQ303145 C303129 CQ303141 CQ303208 CQ303408 CQ303424 CQ303450 CQ303305 CQ303207 CQ303117 CQ303210 CQ303213 CQ303216 CQ303263 C303022 C303078 CQ303125 CQ303230 C303106 C303175 C303177 C303200 CQ303131 CQ303217 CQ303218 CQ303258 CQ303288 CQ303359 CQ303275 C303125 C303171 C303206 C303216 CQ303126 CQ303129 CQ303140 CQ303156 CQ303124 C303070 CQ303135 CQ303173 CQ303423 C303204 CQ303175 CQ303280 CQ303401 CQ303403 CQ303409 C303135 CQ303353 C303209 C303187 P406487 C303207 CQ303261 C303182 CQ303294 C303181 C303186 C303072 C303081 CQ303291 C303184 CQ303123 C303108 C303176 C303179 C303076 C303109 C303173 C303112 C303203 C303183 CQ303225 C303205 CQ303361 CQ303362 C303119 CQ303455 C303107 CQ303419 C303101 CQ303260 CQ303143 CQ303285 CQ303306 CQ303307 CQ303352 CQ303144 CQ303211 CQ303128 CQ303130 CQ303133 C303104 C303105 CQ303134 C303131 CQ303364 C303074 C303079 C303082 C303083 C303084 C303099 C303100 C303103 C303128 C303132 CQ303282 CQ303422 CQ303407 CQ303132 CQ303138 CQ303405 C303111 CQ303430 CQ303103 C303211 CQ303127 CQ303406 C303202 CQ303107 CQ303292 CQ303001 CQ303137 CQ303202 CQ303205 CQ303215 CQ303270 CQ303271 CQ303272 CQ303273 CQ303274 CQ303287 CQ303290 CQ303295 CQ303296 CQ303297 CQ303298 CQ303299 CQ303300 CQ303301 CQ303302 C303110 C303178 C303208 CQ303121 C303073 CQ303214 C303126 C303213 CQ303100 CQ303101 CQ303102 CQ303104 CQ303105 CQ303106 C303185 CQ303308 CQ303350 C303219 C303233 CQ303309 C303170 C303212 C303218 CQ303206 C303113 CQ303351 CQ303420 CQ303425 CQ303289 CQ303354 CQ303428 CQ303421 CQ303426 CQ303262 CQ303355 CQ303357 CQ303358 CQ303356 C303050A C303159 C303165 C303131 C303133 C303228 C303229 C303232 CQ303139 CQ303263 CQ303400 CQ303402 C303056 C303166 CQ303146 CQ303231 Part 330053R: SN C303201 C303075 C303210 C303215 C303180 C303231 Part 330057: SN C303602 C303320 C303284 C303347 C303954 C303357 C303482 C303395 C303324 C303325 C303926 C303316 C303343 C303927 C303258 C304077 C303370 C303371 C303319 C303396 C303283 C303940 C303455 C303335 C303354 C303355 C303356 C303358 C303359 C303360 C303394 C303941 C303942 C303372
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.
  • Description du dispositif
    Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs. /136 kg. || Lifting aid used by health care professionals to lift, position, and transfer clients or disabled family members.
  • Manufacturer
    ErgoSafe Products, LLC (DBA) Prism Medical

Manufacturer

ErgoSafe Products, LLC (DBA) Prism Medical
  • Adresse du fabricant
    ErgoSafe Products, LLC (DBA) Prism Medical, 10888 Metro Ct, Maryland Heights MO 63043-2413
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA