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U.S. Department of Health and Human Services

Class 2 Device Recall Masimo RadG, Pulse Oximeter with temperature (W/Sensor)

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  Class 2 Device Recall Masimo RadG, Pulse Oximeter with temperature (W/Sensor) see related information
Date Initiated by Firm February 15, 2024
Date Posted April 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-1536-2024
Recall Event ID 94170
510(K)Number K213676  
Product Classification Oximeter - Product Code DQA
Product Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Code Information UDI: (01)00843997008013/Serial Numbers: 6000083855 6000083985 6000083987 6000083992 6000083996 6000084000 6000084003 6000084005 6000084009 6000084010 6000084012 6000084013 6000084015 6000084016 6000084038 6000084046 6000084052 6000084057 6000084059 6000084060 6000084064 6000084067 6000084071 6000084080 6000084134 6000084140 6000084165 6000084175 6000084184 6000084192 6000084196 6000084197 6000084200 6000084201 6000084202 6000084207 6000084266 6000084278 6000084279 6000084280 6000084282 6000084284 6000084285 6000084286 6000084287 6000084288 6000084289 6000084296 6000084299 6000084306 6000084310 6000084313 6000084314 6000084315 6000084317 6000084318 6000084319 6000084321 6000084325 6000084326 6000084328 6000084329 6000084331 6000084332 6000084398 6000084410 6000084418 6000084424 6000084478 6000084481 6000084512 6000084546 6000084553 6000084554 6000084556 6000084562 6000084565 6000084566 6000084580 6000084583 6000084590 6000084591 6000084592 6000084593 6000084594 6000084596 6000084598 6000084600 6000084602 6000084604 6000084609 6000084610 6000084615 6000084618 6000084620 6000084624 6000084625 6000084627 6000084629 6000084633 6000084634 6000084635 6000084636 6000084637 6000084638 6000084640 6000083850 6000083851 6000083852 6000083853 6000083857 6000083858 6000083859 6000083860 6000083861 6000083863 6000083866 6000083867 6000083868 6000083869 6000083871 6000083872 6000083873 6000083874 6000083876 6000083879 6000083888 6000083891 6000083893 6000083895 6000083896 6000083903 6000083904 6000083905 6000083907 6000083908 6000083913 6000083914 6000083915 6000083916 6000083918 6000083919 6000083920 6000083923 6000083924 6000083925 6000083929 6000083930 6000083934 6000083943 6000083944 6000083948 6000083950 6000083956 6000083960 6000083962 6000083965 6000083966 6000083967 6000083970 6000083972 6000083977 6000083979 6000083980 6000083982 6000083984 6000083986 6000083995 6000083998 6000084001 6000084006 6000084007 6000084017 6000084021 6000084024 6000084025 6000084031 6000084032 6000084033 6000084035 6000084036 6000084037 6000084040 6000084041 6000084043 6000084044 6000084048 6000084050 6000084051 6000084056 6000084058 6000084062 6000084063 6000084068 6000084072 6000084074 6000084078 6000084081 6000084082 6000084083 6000084085 6000084087 6000084088 6000084091 6000084094 6000084095 6000084096 6000084097 6000084098 6000084099 6000084100 6000084104 6000084107 6000084108 6000084109 6000084111 6000084114 6000084115 6000084116 6000084118 6000084119 6000084123 6000084126 6000084127 6000084131 6000084136 6000084137 6000084138 6000084139 6000084141 6000084142 6000084143 6000084146 6000084147 6000084148 6000084150 6000084151 6000084152 6000084153 6000084154 6000084155 6000084156 6000084158 6000084159 6000084161 6000084162 6000084166 6000084167 6000084168 6000084169 6000084171 6000084172 6000084173 6000084177 6000084178 6000084179 6000084182 6000084183 6000084189 6000084191 6000084193 6000084194 6000084195 6000084199 6000084206 6000084210 6000084214 6000084215 6000084227 6000084228 6000084229 6000084230 6000084234 6000084235 6000084237 6000084238 6000084239 6000084240 6000084241 6000084242 6000084243 6000084245 6000084246 6000084247 6000084248 6000084249 6000084251 6000084252 6000084253 6000084254 6000084255 6000084257 6000084258 6000084259 6000084260 6000084261 6000084262 6000084265 6000084268 6000084269 6000084273 6000084275 6000084283 6000084291 6000084292 6000084294 6000084297 6000084300 6000084301 6000084302 6000084303 6000084304 6000084308 6000084323 6000084324 6000084334 6000084335 6000084336 6000084338 6000084339 6000084340 6000084341 6000084342 6000084343 6000084344 6000084345 6000084346 6000084347 6000084348 6000084349 6000084350 6000084351 6000084352 6000084355 6000084358 6000084372 6000084373 6000084374 6000084375 6000084376 6000084377 6000084378 6000084379 6000084380 6000084381 6000084382 6000084383 6000084384 6000084385 6000084386 6000084387 6000084388 6000084389 6000084393 6000084396 6000084402 6000084406 6000084415 6000084420 6000084422 6000084426 6000084427 6000084428 6000084431 6000084438 6000084456 6000084458 6000084477 6000084479 6000084480 6000084483 6000084484 6000084485 6000084486 6000084487 6000084488 6000084489 6000084490 6000084491 6000084492 6000084493 6000084495 6000084496 6000084503 6000084516 6000084517 6000084518 6000084519 6000084520 6000084521 6000084522 6000084525 6000084526 6000084527 6000084528 6000084532 6000084549 6000084552 6000084557 6000084559 6000084560 6000084561 6000084570 6000084572 6000084576 6000084577 6000084579 6000084581 6000084584 6000084587 6000084588 6000084589 6000084595 6000084599 6000084601 6000084603 6000084605 6000084611 6000084616 6000084619 6000084621 6000084623 6000084631 6000084632 6000084639 6000084641 6000084642 6000084643 6000084646 6000084648
Recalling Firm/
Manufacturer		 Masimo Corporation
52 Discovery
Irvine CA 92618-3105
Manufacturer Reason
for Recall		 Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
FDA Determined
Cause 2		 Material/Component Contamination
Action On February 14, 2024 Masimo issued a "Urgent: Medical Device Recall Notice" via FedEx and US Mail to affected consignees. On February 29, 2024, Masimo issued an updated communication to provide additional information. Masimo's asked consignees to take the following actions: " Please assess your inventory to confirm if you have Rad-G devices listed in Attachment 2-part number(s) and serial number(s). " If you identify affected Rad-G¿ devices, please promptly remove them from use and follow the steps below. " Contact Masimo Technical Services to request return of the affected part and serial number (s) for repair or replacement. " Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023.
Quantity in Commerce 430 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = Masimo Corporation
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