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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0050-2025

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

Publicado el 16 de octubre de 2024 · Inicio del retiro: 22 de agosto de 2024

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

Qué peligro representa

Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Navigation, Inc.
Distribuidor
Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.
Lote
Product Number: 9735762 UDI-DI code: 00763000456986 Serial Numbers: 420002290 N06805776 N07323682 N07323683 N07323687 N07326235 N07334454 N07334475 N07338479 N07338480 N07338482 N07338929 N07354639 N07354642 N07354643 N07354644 N07354645 N07355155 N07357492 N07357493 N07360505 N07360506 N07362322 N07362323 N07364218 N07364220 N07364221 N07365158 N07365160 N07365163 N07365164 N07369302 N07369307 N07401810 N07401811 N07401812 N07401813 N07407569 N07418140 N07418141 N07426193 N07427592 N07427593 N07427597 N07428130 N07428133 N07428134 N07428190 N07428192 N07428193 N07428195 N07428197 N07429001 N07436071 N07436073 N07436074 N07438127 N07438128 N07441426 N07441431 N07448170 N07448371 N07448372 N07449575 N07460062 N07460064 N07461619 N07465933 N07469095 N07469096 N07469097 N07469100 N07469789 N07470357 N07470358 N07471822 N07471823 N07475369 N07475370 N07482977 N07505369 N07508757 N07511354 N07511355 N07511359 N07516935 N07525093 N07525094 N07525099 N07529455 N07533927 N07533928 N07533929 N07533930 N07533931 N07533932 N07533933 N07534178 N07534179 N07534180 N07534655 N07534660 N07536564 N07540834 N07540836 N07540840 N07546674 N07546675 N07546676 N07546679 N07546680 N07547570 N07549763 N07549764 N07550571 N07550577 N07552479 N07565206 N07565587 N07579210 N07579211 N07579475 N07581415 N07585678 N07587632 N07587633 N07587635 N07587636 N07587637 N07587859 N07587861 N07587862 N07587863 N07590349 N07590350 N07590351 N07594577 N07594578 N07594581 N07595330 N07595342 N07596952 N07598116 N07605593 N07612697 N07618329 N07620549 N07803571 N07803573 N07803575 N07806782 N07807286 N07807287 N07807288 N07807289 N07807290 N07807291 N07807292 N07807293 N07807294 N07818055 N07818056 N07819346 N07819352 N07819353 N07822371 N07822379 N07826933 N07828615 N07844635 N07845660 N07845663 N07845671 N07858648 N07858649 N07858650 N07858651 N07858652 N07861405 N07864096 N07864097 N07864098 N07874891 N07874892 N07874895 N07874896 N07874899 N07882341 N08074937 N08074938 N08078498 N08081904 N08085721 N08085722 N08087068 N08089998 N08089999 N08091630 N08098821 N08098826 N08108825 N08108827 N08108828 N08112922 N08117758 N08117759 N08118873 N08122313 N08123244 N08127267 N08127268 N08128176 N08128180 N08128181 N08135030 N08135036 N08135049 N08135455 N08135456 N08146120 N08147667 N08147668 N08147669 N08149571 N08149572 N08149573 N08149574 N08149575 N08149671 N08153886 N08158320 N08159975 N08159977 N08159978 N08161541 N08161542 N08166269 N08167831 N08169640 N08169641 N08169642 N08176344 N08176345 N08177679 N08177680 N08184135 N08184138 N08184139 N08184856 N08184857 N08184858 N08184861 N08184862 N08184863 N08188260 N08188261 N08191893 N08198975 N08200845 N08200846 N08201073 N08203529 N08203530 N08206836 N08208307 N08208308 N08208309 N08212626 N08212627 N08213736 N08213737 N08213739 N08214754 N08218322 N08218323 N08218324 N08223527 N08223864 N08223865 N08223867 N08223868 N08223869 N08224684 N08224688 N08226285 N08231672 N08231673 N08231674 N08231675 N08231677 N08231678 N08231679 N08232081 N08232083 N08232084 N08232597 N08238074 N08238077 N08238078 N08238079 N08239471 N08239472 N08239473 N08239474 N08239475 N08245854 N08245855 N08245856 N08245863 N08246867 N08246870 N08248354 N08248355 N08248357 N08248358 N08248359 N08250623 N08250625 N08257411 N08257412 N08257413 N08259495 N09734896 N09736342 N09736343 N09736344 N09736346 N09736588 N09736594 N09736595 N09736596 N09736597 N09739964 N09739965 N09739966 N09739967 N09740159 N09740160 N11707446 N11707447 N11707774 N11707775 N11707776 N11707777 N11715900 N11715901 N11717901 N11724973 N29251669 N29251670 N29255589 N29255590 N29259317 N29259318 N29259320 N29259321 N29259324 N29457787 N29457788 N29457789 N29457790 N29457791 N29457792 N29475311 N29475312 N29475313 N29475314 N29475318 N29475319 N29475325 N29475326 N29475327 N29475328 N29476198 N29476199 N29476770 N29476771 N29476772 N29483351 N29487528 N29487529 N29487530 N29487531 N29500856 N29500951 N29501829 N29501831 N29507962 N29507963 N29509090 N29509091 N29510153 N29510154 N2
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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