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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2122-2014

InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.

Publicado el 6 de agosto de 2014 · Inicio del retiro: 4 de junio de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Medical Division of Stryker Corporation
Distribuidor
Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.
Lote
Model 2130 T01168 T01723 T01331 T02213 T02554 T01544 T01167 T01722 T01330 T02212 T02553 T01609 T01166 T01721 T01329 T02211 T02552 T01608 T01165 T01310 T01328 T02210 T02551 T01543 T01164 T02089 T01327 T02209 T02550 T02515 T01163 T01967 T01326 T02208 T02549 T02514 T01162 T01966 T01325 T02207 T02173 T02513 T01161 T01965 T01324 T02206 T02172 T01613 T01160 T01964 T01323 T02205 T02171 T01612 T02644 T01963 T01322 T02204 T02170 T01611 T02068 T01962 T01321 T02203 T02169 T01610 T02067 T01961 T01699 T02202 T02168 T02174 T02066 T01960 T01698 T02201 T02167 T02180 T02512 T01959 T01697 T02200 T02166 T02179 T02511 T01958 T01696 T02199 T01931 T02178 T02510 T01957 T01695 T02198 T01930 T02177 T02509 T01956 T01665 T02197 T01929 T02176 T02508 T01955 T01664 T02196 T01928 T02175 T02507 T01954 T01663 T02152 T01927 T01572 T02506 T01953 T01662 T01369 T01926 T01548 T01388 T01952 T01661 T01368 T01925 T01547 T01387 T01951 T02237 T01377 T01924 T01526 T01386 T01950 T02236 T01376 T01923 T01525 T01385 T01949 T02235 T01375 T01922 T02660 T01384 T01948 T02234 T01374 T01921 T02659 T02077 T02239 T02233 T01373 T01920 T02090 T02076 T02256 T02232 T01372 T01919 T02088 T02075 T02255 T02231 T01371 T01918 T01971 T01720 T02087 T02230 T01370 T01917 T01970 T01719 T02086 T02229 T01689 T01916 T01933 T01718 T01348 T02228 T01688 T01915 T01419 T02065 T01347 T02227 T01687 T01914 T01418 T02064 T01346 T02226 T01686 T01913 T01417 T02063 T01345 T02225 T01685 T01912 T01416 T02062 T01344 T02224 T01684 T01911 T01415 T02061 T01343 T02223 T01683 T01910 T01414 T02060 T01342 T02222 T01682 T01909 T01413 T02059 T01341 T02221 T02564 T01908 T01412 T02058 T01340 T02220 T02563 T01907 T01411 T02016 T01339 T02219 T02090 T01906 T01410 T02015 T01338 T02218 T02088 T01905 T01409 T02014 T01337 T02217 T01555 T01551 T01408 T02013 T01336 T02216 T01554 T01550 T01407 T02012 T01335 T02215 T01553 T01546 T01406 T02011 T01332 T02214 T01552 T01545 T01405 T01401 T02566 T02565 T01404 Model 2131 U04413 U03329 U08829 U51367 U06561 U01013 U04412 U03328 U03872 U51366 U06560 U01012 U04411 U50318 U03871 U51365 U03270 U05809 U04410 U50317 U03870 U51364 U03269 U01621 U04409 U50316 U03869 U51363 U03268 U07592 U04408 U50315 U03868 U51362 U03267 U04982 U04407 U50314 U03867 U51361 U03266 U04981 U04406 U50313 U03866 U50581 U03265 U06925 U04405 U50312 U03865 U50580 U03264 U08990 U04404 U50311 U03074 U50579 U03263 U08602 U04403 U01739 U03010 U50578 U02613 U08601 U04402 U01738 U03009 U50577 U02612 U08600 U04401 U01737 U03008 U50576 U02611 U08599 U04400 U01736 U05467 U50419 U51206 U08598 U04399 U01735 U05466 U50418 U51205 U08597 U04398 U01734 U05465 U50417 U51204 U08596 U04397 U01733 U05464 U50416 U51203 U08595 U04396 U01732 U05463 U50415 U51202 U08594 U04395 U01731 U05462 U50414 U08737 U08593 U04394 U01730 U05461 U50413 U08736 U08592 U03062 U01729 U05460 U50412 U08735 U08591 U03061 U01728 U05459 U50411 U08734 U08590 U03060 U51160 U05458 U50410 U08733 U08589 U01259 U08722 U05457 U50409 U08732 U08588 U01258 U08721 U05456 U50404 U03660 U08587 U01257 U08720 U05455 U50403 U03659 U08586 U04577 U08719 U05454 U50402 U03658 U08585 U04422 U08718 U06914 U50401 U03657 U08584 U02179 U08717 U06913 U50400 U03656 U08583 U02178 U08716 U06912 U50399 U03655 U08582 U02177 U08715 U06911 U08096 U03654 U08581 U02176 U08714 U06910 U08095 U03653 U08580 U02175 U08713 U06909 U08094 U03652 U08579 U02174 U08712 U06908 U08093 U03651 U08578 U02173 U08711 U06907 U08085 U03650 U08577 U02172 U08710 U01401 U08084 U03649 U08576 U02171 U08709 U01400 U08083 U03648 U08575 U02861 U08708 U01399 U08082 U03647 U08574 U02860 U08707 U01398 U08081 U03646 U08573 U02859 U04949 U04372 U08080 U03645 U08572 U02858 U04948 U04371 U08079 U03644 U08571 U02857 U04947 U04370 U08078 U03643 U08570 U02856 U04946 U04369 U08077 U03642 U08569 U02855 U04945 U04368 U08076 U03641 U08568 U02854 U04944 U04367 U06733 U03640 U08567 U02853 U02921 U04366 U06732 U03639 U08566 U02852 U02920 U04
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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