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  "name": "Intera 1.5T Explorer/Nova Dual  Product Number: 781108;",
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      "name": "FDA recall Z-1932-2025: Philips North America is recalling Intera 1.5T Explorer/Nova Dual  Product Number: 781108;",
      "text": "The FDA logged enforcement record Z-1932-2025: Philips North America is voluntarily recalling Intera 1.5T Explorer/Nova Dual  Product Number: 781108; — reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-29. Affected lots/codes: Product Number: 781108; UDI-DI: no UDI; Serial Number: 9025;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1932-2025 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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      "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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