SIGNA Creator, SIGNA Explorer, NMRI systems
type: Dataset
description: FDA recall Z-1239-2025 — GE Healthcare (China) Co., Ltd. is recalling SIGNA Creator, SIGNA Explorer, NMRI systems (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: SIGNA Creator, SIGNA Explorer, NMRI systems
  type: MedicalDevice
  manufacturer: GE Healthcare (China) Co., Ltd.
claims: FDA recall Z-1239-2025: GE Healthcare (China) Co., Ltd. is recalling SIGNA Creator, SIGNA Explorer, NMRI systems
claims: FDA classified recall Z-1239-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1239-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1239-2025
      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: GE Healthcare (China) Co., Ltd.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-01-31
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 1. Creator A. UDI-DI 00195278577221, System ID MR00160 MR00171 MR00189 THMR54503051 (Update 12/29/25 - New System ID MRR10626) (Update 1/28/26 - New System IDs MRR10269 850270138) (Update 2/19/26 - Addl System IDs MR00299¿ PHMRI24836517 12440397 13131449¿ PC0084) B. UDI-DI 00195278577238, System ID 083027026539324 5973MR0087 5973MR0091 5973MR0095 5973MR0096 5973MR0097 5973MR0100 5973MR0103 5973MR0104 5973MR0106 5973MR0107 5973MR0109 9830MR0112 9830MR0113 9830MR0114 9830MR0117 A199750201 IDMRI24467771 MR00082 MR00111 MR00120 MR00138 MR00140 MR00143 MR00152 MR00157 MR00174 MR00179 MR00180 MR00187 MR00191 MR00192 MR00195 MR00210 MR00229 MR00231 MR00236 MR00249 MR00251 MR00258 MR00263 MR00282 MRR1170 MRR1182 MRR2198 MRR2508 MRR2860 MRR2916 MRR2938 MRR3171 MRR3873A MRR3954 MRR4356 MRR4501 MRR4726 MRR493 MRR5138 MRR5332 MRR5494 MRR5684 MRR569A MRR6219 MRR673 MRR7117 MRR9626 MRYR2151 VNMRI24476142 VNMRI24513835 (Updated 12/29/25 - Additional System IDs MRR3679 , MR00322) (Updated 2/19/26 - Additional System IDs 83027280426725 83027280425025 MR00219 VNMRI24845558 THMRI25011164¿) C. UDI-DI 00840682113762, System ID 6529149 7361387 07143820 082427030212 082427040272 082427040285 082427060095 082427060119 082427070318 082427080107 082427080129 082427090384 082427090403 082427090419 082427090433 082427090434 082427090436 082427090448 082427100397 082427100418 082427110140 082427120326 082427120330 082427130173 082427160292 082427160307 082427160310 082427160318 082427160319 082427160343 082427160375 082427200201 082427200216 082427220123 082427220126 082427230245 082427230253 082427250094 082427250096 082427250122 082427290064 082427310174 0828270077 0850270635 0850270645 0850270695 0850270772 1553MR0020 1557MR0052 1573MR0064 5973MR0073 7982MR0048 A5421025 A5816111 HU1729MR01 MR00017 MR00018 MR00042 MR51028441 MRR1577 MRR192 MRRD1008 MRRD1027 MRRD1205 MRRD1331 MRRD1376 PC6242 PC6249 PC6261 PC6264 PC6273 PC6277 PC6286 PPS16207 RF1647MR01 RF3314MR01 RU1115MR01 RU2144MR01 RU3261MR…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Domestic US distribution nationwide. International distribution worldwide.
      status: recorded

FDA recall Z-1239-2025: GE Healthcare (China) Co., Ltd. is recalling SIGNA Creator, SIGNA Explorer, NMRI systems
type: Claim
text: The FDA logged enforcement record Z-1239-2025: GE Healthcare (China) Co., Ltd. is voluntarily recalling SIGNA Creator, SIGNA Explorer, NMRI systems — reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-31. Affected lots/codes: 1. Creator A. UDI-DI 00195278577221, System ID MR00160 MR00171 MR00189 THMR54503051 (Update 12/29/25 - New System ID MRR10626) (Update 1/28/26 - New System IDs MRR10269 850270138) (Update 2/19/26 - Addl System IDs MR00299¿ PHMRI24836517 12440397 13131449¿ PC0084) B. UDI-DI 00195278577238, System ID 083027026539324 5973MR0087 5973MR0091 5973MR0095 5973MR0096 5973MR0097 5973MR0100 5973MR0103 5973MR0104 5973MR0106 5973MR0107 5973MR0109 9830MR0112 9830MR0113 9830MR0114 9830MR0117 A199750201 IDMRI24467771 MR00082 MR00111 MR00120 MR00138 MR00140 MR00143 MR00152 MR00157 MR00174 MR00179 MR00180 MR00187 MR00191 MR00192 MR00195 MR00210 MR00229 MR00231 MR00236 MR00249 MR00251 MR00258 MR00263 MR00282 MRR1170 MRR1182 MRR2198 MRR2508 MRR2860 MRR2916 MRR2938 MRR3171 MRR3873A MRR3954 MRR4356 MRR4501 MRR4726 MRR493 MRR5138 MRR5332 MRR5494 MRR5684 MRR569A MRR6219 MRR673 MRR7117 MRR9626 MRYR2151 VNMRI24476142 VNMRI24513835 (Updated 12/29/25 - Additional System IDs MRR3679 , MR00322) (Updated 2/19/26 - Additional System IDs 83027280426725 83027280425025 MR00219 VNMRI24845558 THMRI25011164¿) C. UDI-DI 00840682113762, System ID 6529149 7361387 07143820 082427030212 082427040272 082427040285 082427060095 082427060119 082427070318 082427080107 082427080129 082427090384 082427090403 082427090419 082427090433 082427090434 082…
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-1239-2025 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.