FDAFDA · Food and drugs·Recall number Z-1538-2024
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Published April 24, 2024 · Recall initiated: February 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Masimo Corporation
- Distributor
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Belize, Bolivia, Burkina Faso, Burundi, Cambodia, Canada, Chile, Colombia, Congo, The Democratic Republic of, Costa Rica, Cyprus, Czech Republic, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Lesotho, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Poland, Puerto Rico, Qatar, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tanzania, United Republic Of, Thailand, Trinidad And Tobago, Uganda, United Kingdom, Uruguay, Yemen, Zimbabwe.
- Lot
- UDI:(01)00843997000666/Serial Number: 6000063773 6000063918 6000064156 6000064251 6000064298 6000065602 6000066119 6000066282 6000066408 6000066411 6000066442 6000066476 6000066577 6000066623 6000066856 6000067119 6000067120 6000067122 6000067134 6000067140 6000067142 6000067145 6000067150 6000067151 6000067162 6000067163 6000067167 6000067168 6000067170 6000067173 6000067175 6000067176 6000067177 6000067178 6000067179 6000067180 6000067182 6000067183 6000067185 6000067186 6000067188 6000067192 6000067193 6000067194 6000067196 6000067198 6000067201 6000067202 6000067207 6000067211 6000067224 6000067225 6000067235 6000067241 6000067245 6000067246 6000067247 6000067252 6000067256 6000067269 6000067272 6000067278 6000067293 6000067300 6000067309 6000067311 6000067312 6000067314 6000067345 6000067356 6000067357 6000067360 6000067366 6000067367 6000067418 6000067443 6000067446 6000067472 6000067475 6000067482 6000067484 6000067486 6000067496 6000067515 6000067552 6000067563 6000067584 6000067609 6000067625 6000067626 6000067629 6000067642 6000067658 6000067660 6000067662 6000067663 6000067673 6000067679 6000067680 6000067686 6000067689 6000067695 6000067701 6000067702 6000067710 6000067711 6000067718 6000067721 6000067729 6000067730 6000067732 6000067736 6000067751 6000067752 6000067757 6000067760 6000067764 6000067780 6000067783 6000067790 6000067807 6000067824 6000067832 6000067833 6000067838 6000067839 6000067849 6000067853 6000067864 6000067902 6000067906 6000067921 6000067922 6000067925 6000067926 6000067944 6000067959 6000067963 6000067993 6000068018 6000068042 6000068074 6000068120 6000068140 6000068226 6000068259 6000068262 6000068273 6000068274 6000068295 6000068301 6000068307 6000068311 6000068325 6000068327 6000068332 6000068333 6000068385 6000068386 6000068390 6000068391 6000068404 6000068406 6000068422 6000068437 6000068438 6000068440 6000068451 6000068452 6000068477 6000068489 6000068493 6000068494 6000068498 6000068503 6000068516 6000068522 6000068524 6000068569 6000068582 6000068592 6000068593 6000068638 6000068644 6000068648 6000068691 6000068725 6000068733 6000068736 6000068743 6000068749 6000068768 6000068785 6000068830 6000068835 6000068836 6000068838 6000068840 6000068841 6000068842 6000068843 6000068844 6000068845 6000068846 6000068849 6000068850 6000068851 6000068852 6000068857 6000068862 6000068867 6000068871 6000068874 6000068875 6000068877 6000068878 6000068880 6000068882 6000068888 6000068890 6000068892 6000068893 6000068896 6000068898 6000068900 6000068902 6000068903 6000068904 6000069017 6000069018 6000069020 6000069023 6000069029 6000069031 6000069037 6000069050 6000069056 6000069094 6000069105 6000069106 6000069109 6000069112 6000069113 6000069114 6000069115 6000069117 6000069119 6000069120 6000069121 6000069122 6000069126 6000069134 6000069153 6000069159 6000069160 6000069162 6000069164 6000069165 6000069173 6000069176 6000069177 6000069178 6000069181 6000069182 6000069185 6000069186 6000069187 6000069189 6000069192 6000069193 6000069194 6000069208 6000069211 6000069218 6000069219 6000069222 6000069249 6000069252 6000069253 6000069255 6000069262 6000069272 6000069273 6000069284 6000069294 6000069302 6000069304 6000069305 6000069306 6000069308 6000069309 6000069310 6000069312 6000069313 6000069314 6000069315 6000069316 6000069317 6000069318 6000069319 6000069320 6000069321 6000069322 6000069325 6000069327 6000069329 6000069330 6000069332 6000069335 6000069337 6000069338 6000069341 6000069348 6000069357 6000069358 6000069360 6000069361 6000069362 6000069364 6000069365 6000069366 6000069368 6000069371 6000069380 6000069395 6000069408 6000069409 6000069429 6000069447 6000069449 6000069450 6000069452 6000069457 6000069458 6000069462 6000069464 6000069465 6000069467 6000069468 6000069469 6000069470 6000069471 6000069472 6000069473 6000069475 6000069476 6000069477 6000069480 6000069481 6000069482 6000069528 6000069532 6000069536 6000069539 6000069556 6000069558 6000069561 6000069566 6000069568 6000069570 60
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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