Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
type: Dataset
description: FDA recall Z-1537-2024 — Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, 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/Sensor), REF:9847, Rx Only,
  type: MedicalDevice
  manufacturer: Masimo Corporation
claims: FDA recall Z-1537-2024: Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
claims: FDA classified recall Z-1537-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1537-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1537-2024
      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)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 6000062126 6000062127 6000062128 6000062129 6000062130 6000062131 6000062132 6000062133 6000062134 6000062135 6000062136 6000062137 6000062138 6000062139 6000062140 6000062141 6000062142 6000062143 6000062144 6000062145 6000062146 6000062147 6000062148 6000062149 6000062150 6000062151 6000062152 6000062153 6000062154 6000062155 6000062156 6000062157 6000062158 6000062159 6000062160 6000062161 6000062162 6000062163 6000062164 6000062165 6000062166 6000062167 6000062168 6000062169 6000062170 6000062171 6000062172 6000062173 6000062174 6000062175 6000062176 6000062177 6000062178 6000062179 6000062180 6000062181 6000062182 6000062183 6000062184 6000062185 6000062186 6000062187 6000062188 6000062189 6000062190 6000062191 6000062192 6000062194 6000062195 6000062196 6000062197 6000062198 6000062199 6000062200 6000062201 6000062202 6000062203 6000062204 6000062205 6000062206 6000062207 6000062208 6000062209 6000062210 6000062211 6000062212 6000062213 6000062214 6000062215 6000062216 6000062217 6000062218 6000062219 6000062220 6000062221 6000062222 6000062223 6000062224 6000062225 6000062226 6000062227 6000062228 6000062229 6000062230 6000062231 6000062232 6000062233 6000062234 6000062235 6000062236 6000062237 6000062238 6000062239 6000062240 6000062241 6000062242 6000062243 6000062244 6000062245 6000062246 6000062247 6000062248 6000062249 6000062250 6000062251 6000062252 6000062253 6000062254 6000062255 6000062256 6000062257 6000062258 6000062259 6000062260 6000062261 6000062262 6000062263 6000062264 6000062265 6000062266 6000062267 6000062268 6000062269 6000062270 6000062271 6000062272 6000062273 6000062274 6000062275 6000062276 6000062277 6000062278 6000062279 6000062280 6000062281 6000062282 6000062283 6000062284 6000062285 6000062286 6000062287 6000062288 6000062289 6000062291 6000062292 6000062293 6000062294 6000062295 6000062296 6000062297 6000062298 60…
      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-1537-2024: Masimo Corporation is recalling Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
type: Claim
text: The FDA logged enforcement record Z-1537-2024: Masimo Corporation is voluntarily recalling Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, 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)00843997013284/ Serial Numbers: 6000062119 6000062120 6000062121 6000062122 6000062123 6000062124 6000062125 6000062126 6000062127 6000062128 6000062129 6000062130 6000062131 6000062132 6000062133 6000062134 6000062135 6000062136 6000062137 6000062138 6000062139 6000062140 6000062141 6000062142 6000062143 6000062144 6000062145 6000062146 6000062147 6000062148 6000062149 6000062150 6000062151 6000062152 6000062153 6000062154 6000062155 6000062156 6000062157 6000062158 6000062159 6000062160 6000062161 6000062162 6000062163 6000062164 6000062165 6000062166 6000062167 6000062168 6000062169 6000062170 6000062171 6000062172 6000062173 6000062174 6000062175 6000062176 6000062177 6000062178 6000062179 6000062180 6000062181 6000062182 6000062183 6000062184 6000062185 6000062186 6000062187 6000062188 6000062189 6000062190 6000062191 6000062192 6000062194 6000062195 6000062196 6000062197 6000062198 6000062199 6000062200 6000062201 6000062202 6000062203 6000062204 6000062205 6000062206 6000062207 6000062208 6000062209 6000062210 6000062211 6000062212 6000062213 6000062214 6000062215 6000062216 6000062217 6000062218 6000062219 6000062220 6000062221 6000062222 6000062223 6000062224 6000062225 6000062226 6000062227 6000062228 6000062229 6000062230 6000062231 6000062232 6000062233 6000062234 6000062235 6000062236 6000062237 6000062238 6000062239 6000062240 6000062241 6000062242 6000062243 6000062244 6000062245 6000062246 6000062247 6000062248 6000062249 6000062250 6000062251 6000062252 6000062253 6000062254 6000062255 6000062256 6000062257 6000062258 6000062259 6000062260 6000062261 6000062262 6000062263 6000062264…
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-1537-2024 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.