FDAFDA · Alimentos y medicamentos·N.º oficial Z-0110-2015
Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Publicado el 29 de octubre de 2014 · Inicio del retiro: 7 de octubre 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
Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Mortara Instrument, Inc
- Distribuidor
- Worldwide Distribution: US (Nationwide) in the states of: AZ, AR, CA, DC, FL, ID, IL IN, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NJ, NY, NC, OK PA, SC, TN, TX, VA, and WI; and internationally to: AUSTRALIA, BANGLADESH, CANADA, CHILE, CROATIA, EGYPT, GERMANY, ITALY, JORDAN, LEBANON, MALAYSIA, MOROCCO, OMAN, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, THAILAND, THE NETHERLANDS, UNITED KINGDOM.
- Lote
- Unit Serial Number 113400177138 113400177139 114260218985 114260218986 114260218987 114360228306 114330225509 114330225510 114330225511 114330225512 114330225513 114330225514 114330225515 114330225516 113430180113 114100196465 114040191976 114090196324 113490185858 113490185860 112090110348 113030149744 113030149745 113460182773 113460182774 113460182775 113460182776 113460182777 113460182778 113460182779 113460182780 113460182781 113460182782 113460182783 113460182784 113460182785 113460182786 113470184344 112090110349 112090110359 112090110360 112100110533 112100110538 112480143971 112480143973 112480143974 112490144251 112490144252 112490144253 112490144254 112490144255 113030149224 113030149746 113030149747 113030149748 113030149749 113030149750 113110157148 113110157149 113230166552 113230166553 113230166554 113230166555 113230166556 113230166557 113280169582 113300171794 113300171795 113450181352 113450181353 113450181354 113450181355 113450181497 113450181498 113450181499 113450181500 113450181501 113450181502 113450181640 113450181641 113450181642 113450181643 113460182680 113460182681 113460182682 113460182683 113460182684 113460182685 113460182768 113460182769 113460182770 113460182771 113470184286 113470184290 113470184291 113490185852 113490185853 113490185857 114100200986 114150205554 114150205559 114150205560 114150205561 114180209641 114230216030 114230216031 114230216032 114230216033 114230216189 114230216190 114270220481 114270220482 114270220483 114270220484 114270220485 114270220486 114270220487 114270220488 114320223837 114320223838 114320223839 114320223840 114170207573 114170207578 114170207571 113400177141 113400177143 114200211466 114200211467 114200211468 114200211469 114200211470 114300222151 114300222152 114180209529 114200211644 114270220219 113500187610 113500187611 113500187612 113500187613 113500187614 114170207574 114170207575 114170207576 114180208865 114180208866 114170207572 114170207577 114110202128 114110202129 114110202130 114110202131 114110202132 113460182787 113470184288 113470184289 113020149035 113240166896 113240166897 113240166898 113240166899 113240166900 113240166901 113240166902 113240166903 113240166904 113240166905 113240166906 113240166907 113240166909 113240166910 113240166911 113240166912 113240166913 113240166914 113240166915 113240166916 113240166917 113240166918 113240166919 113300171783 113300171793 113420179612 113470184292 113020148884 113460183384 113490186369 113490186424 113500187631 114020190148 114230215743 114150205557 114020190126 114020190135 114020190146 114020190147 113490186418 114020190138 114020190149 113510188418 113490186426 114020190139 114020190144 114020190145 114260218675 114330225400 114330225401 114330225402 114330225403 114330225404 114330225405 114330225406 114340226207 114340226208 114360227434 114360227435 114020190123 114020190124 114180209553 114180209554 113490186431 113500187623 113500187625 113500187632 113490186432 113510188607 113510188621 113510188622 113510188623 113510188618 113510188609 113370175199 113370175224 114200211465 113500187622 113500187628 113500187630 113500187633 113410178148 113410178149 113410178150 113410178151 113430179851 113490185879 113490186356 113490186380 113490186395 113490186427 113490186437 113490186440 113500186706 113500187615 113500187616 113500187620 113500187624 113500187627 113500187635 113510188624 113520188912 113520188913 113520188929 113520188930 113520188935 114020190130 114020190131 114020190142 114020190143 114050192815 114330225407 114330225408 114370228759 113370175212 114260219186 114260219187 113520188926 113520188928 113520188931 113420178823 113490186411 113370175194 113410178147 114280221111 113420179615 1134
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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