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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2570-2025.jsonld",
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  "name": "Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.",
  "description": "FDA recall Z-2570-2025 — Philips Medical Systems (Cleveland) Inc is recalling Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques. (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.",
    "manufacturer": {
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      "name": "Philips Medical Systems (Cleveland) Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2570-2025/enforcement-record",
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      "name": "FDA recall Z-2570-2025: Philips Medical Systems (Cleveland) Inc is recalling Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques.",
      "text": "The FDA logged enforcement record Z-2570-2025: Philips Medical Systems (Cleveland) Inc is voluntarily recalling Pinnacle Radiation Therapy Planning System:    Multimodality Simulation Workspace 18.0.5 Model 870258  UDI code: (01)00884838103566(10)18.0.5.22236    Pinnacle TumorLOC 16.2 Model 870226  UDI code: (01)00884838091122(10)16.2.0.60010    Pinnacle TumorLOC 16.2.1 Model 870227  UDI code: (01)00884838091122(10)16.2.1.60098    Pinnacle TumorLOC 16.0.2 Model 870218  UDI code: (01)00884838085602(10)16.0.2.60004    Pinnacle TumorLOC 14.0 Model 870200  UDI code: N/A    Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes.  The full Pinnacle3 Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, electron and brachytherapy techniques. — reason: Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-05. Affected lots/codes: Pinnacle¿ Radiation Therapy Planning System:  Multimodality Simulation Workspace 18.0.5 Model Number: 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Lot Number (Software Version): 18.0.5  Pinnacle TumorLOC 16.2 Model Number: 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Lot Number (Software Version): 16.2  Pinnacle TumorLOC 16.2.1 Model Number: 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Lot Number (Software Version): 16.2.1  Pinnacle TumorLOC 16.0.2 Model Number: 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Lot Number (Software Version): 16.0.2  Pinnacle TumorLOC 14.0 Model Number: 870200 UDI code: N/A Lot Number (Software Version): 14.0. A RECORDED FDA enforcement action (occurred=true).",
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      "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."
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      "name": "FDA classified recall Z-2570-2025 as Class II",
      "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.",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2570-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2570-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
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            "Field": "Reason",
            "Value": "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-08-05",
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            "Field": "Lot/code info",
            "Value": "Pinnacle¿ Radiation Therapy Planning System:  Multimodality Simulation Workspace 18.0.5 Model Number: 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Lot Number (Software Version): 18.0.5  Pinnacle TumorLOC 16.2 Model Number: 870226 UDI code: (01)00884838091122(10)16.2.0.60010 Lot Number (Software Version): 16.2  Pinnacle TumorLOC 16.2.1 Model Number: 870227 UDI code: (01)00884838091122(10)16.2.1.60098 Lot Number (Software Version): 16.2.1  Pinnacle TumorLOC 16.0.2 Model Number: 870218 UDI code: (01)00884838085602(10)16.0.2.60004 Lot Number (Software Version): 16.0.2  Pinnacle TumorLOC 14.0 Model Number: 870200 UDI code: N/A Lot Number (Software Version): 14.0",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.",
            "Status": "recorded"
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