Events

Device Recall Maxi Sky 2 Medium 2Point Spreader Bar 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arjo, Inc. dba ArjoHuntleigh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    63897
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0079-2015
  • 사례 시작날짜
    2013-01-21
  • 사례 출판 날짜
    2014-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114969
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. the loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks.
  • 조치
    URGENT FIELD CORRECTION RECALL letters dated January 21, 2013 were sent to all direct accounts (customers). The letters identified the potential safety related issue; included instructions on how to use the Medium Two Hooks Spreader Bars, and to complete and return the enclosed Customer Response form. Once the Customer Response form has been returned customers will be contacted by an ArjoHuntleigh service representative to make arrangements for the replacement of the existing spreader bars with spreader bars of a different design. Customers with any questions about this recall can contact ArjoHuntleigh by telephone at 800-323-1245, extension 57985, or by e-mail at usa.quality@arjohuntleigh.com.

Device

Device Recall Maxi Sky 2 Medium 2Point Spreader Bar
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 1942500017, 1942500025, 1942500030, 1942500053, 1942500054, 1942500055, 1942500056, 1942500057, 1942500058, 1942500059, 1942500060, 1942500061, 1942500062,  1942500063, 1942500064, 1942500065, 1942500066, 1942500067, 1942500068, 1942500069, 1942500070, 1942500071, 1942500072, 1942500073, 1942500074, 1942500075, 1942500076, 1942500077, 1942500078, 1942500079, 1942500080, 1942500081, 1942500082,  1942500083, 1942500085, 1942500086, 1942500087, 1942500088, 1942500089, 1942500092, 1942500093, 1942500094, 1942500095, 1942500096, 1942500097, 1942500098, 1942500099, 1942500100, 1942500101, 1942500102, 1942500103, 1942500104, 1942500105,  1942500106, 1942500107, 1942500108, 1942500109, 1942500110, 1942500111, 1942500112, 1942500113, 1942500114, 1942500115, 1942500116, 1942500117, 1942500118, 1942500119, 1942500120, 1942500121, 1942500122, 1942500123, 1942500124, 1942500125,  1942500126, 1942500127, 1942500128, 1942500129, 1942500130, 1942500131, 1942500132, 1942500133, 1942500134, 1942500135, 1942500136, 1942500137, 1942500138, 1942500139, 1942500140, 1942500141, 1942500142, 1942500143, 1942500144, 1942500145,  1942500146, 1942500147, 1942500148, 1942500149, 1942500150, 1942500151, 1942500152, 1942500153, 1942500154, 1942500155, 1942500156, 1942500157, 1942500158, 1942500159, 1942500160, 1942500161, 1942500162, 1942500163, 1942500164, 1942500165,  1942500166, 1942500167, 1942500168, 1942500169, 1942500170, 1942500171, 1942500172, 1942500173, 1942500174, 1942500175, 1942500176, 1942500177,  1942500178 1942500179 1942500180 1942500181 1942500182 1942500183 1942500185 1942500186 1942500187 1942500188 1942500189 1942500190 1942500191 1942500192 1942500193 1942500194 1942500195 1942500196 1942500197 1942500198 1942500199 1942500200 1942500201 1942500202 1942500203 1942500204 1942500205 1942500206 1942500207 1942500208 1942500210 1942500211 1942500212 1942500213 1942500214 1942500215 1942500216 1942500217 1942500218 1942500219 1942500221 1942500222 1942500223 1942500224 1942500225 1942500226 1942500227 1942500228 1942500229 1942500231 1942500233 1942500234 1942500235 1942500236 1942500237 1942500238 1942500239 1942500240 1942500241 1942500242 1942500243 1942500244 1942500245 1942500246 1942500247 1942500248 1942500249 1942500250 1942500251 1942500252 1942500253 1942500254 1942500255 1942500256 1942500257 1942500258 1942500259 1942500260 1942500261 1942500262 1942500263 1942500264 1942500265 1942500266 1942500267 1942500268 1942500269 1942500270 1942500271 1942500272 1942500273 1942500274 1942500275 1942500276 1942500277 1942500278 1942500279 1942500280 1942500281 1942500282 1942500283 1942500284 1942500285 1942500286 1942500287 1942500288 1942500289 1942500290 1942500291 1942500292 1942500293 1942500294 1942500297 1942500298 1942500299 1942500300 1942500301 1942500302 1942500303 1942500304 1942500307 1942500308 1942500310 1942500311 1942500312 1942500313 1942500316 1942500317 1942500318 1942500319 1942500320 1942500321 1942500322 1942500323 1942500324 1942500325 1942500326 1942500327 1942500328 1942500329 1942500330 1942500331 1942500332 1942500333 1942500334 1942500335 1942500336 1942500337 1942500338 1942500339 1942500340 1942500342 1942500343 1942500344 1942500345 1942500346 1942500347 1942500348 1942500349 1942500351 1942500352 1942500353 1942500354 1942500355 1942500356 1942500357 1942500358 1942500359 1942500360 1942500361 1942500363 1942500364 1942500366 1942500367 1942500369 1942500370 1942500371 1942500372 1942500373 1942500375 1942500376 1942500377 1942500378 1942500379 1942500380 1942500381 1942500382 1942500383 1942500384 1942500385 1942500386 1942500387 1942500388 1942500389 1942500390 1942500391 1942500392 1942500393 1942500394 1942500395 1942500396 1942500397 1942500398 1942500399 1942500400 1942500401 1942500402 1942500403 1942500404 1942500405, and  1942600003.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Distribution - AR, GA, MI, PA, and the District of Columbia.
  • 제품 설명
    Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. || Intended to be used for general transfers in hospitals.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • 제조사 주소
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA