Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
type: Dataset
description: FDA recall Z-1538-2024 — Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
  type: MedicalDevice
  manufacturer: Masimo Corporation
claims: FDA recall Z-1538-2024: Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
claims: FDA classified recall Z-1538-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1538-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1538-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Masimo Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-02-15
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 6000…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

FDA recall Z-1538-2024: Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
type: Claim
text: The FDA logged enforcement record Z-1538-2024: Masimo Corporation is voluntarily recalling Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, — reason: Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-15. Affected lots/codes: 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 60000…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1538-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.