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  "name": "Philips Incisive CT -Computed Tomography X-Ray System  Model Number: 72814",
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      "name": "FDA recall Z-1585-2023: Philips North America is recalling Philips Incisive CT -Computed Tomography X-Ray System  Model Number: 72814",
      "text": "The FDA logged enforcement record Z-1585-2023: Philips North America is voluntarily recalling Philips Incisive CT -Computed Tomography X-Ray System  Model Number: 72814 — reason: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-20. Affected lots/codes: UDI-DI: (01)00884838105508(21) + Serial number  US Serial Numbers: 550243, 34111, 34092, 34066, 34064, 34047, 34042, 34025, 34031, 34033  OUS Serial Numbers:  System Serial Number 550263 550249 550239 550215 550211 550091 550188 550187 550186 550174 550172 552041 550164 34107 550140 34062 550099 550082 550071 550068 550059 34020 550038 550040 550021 550036 550018 550014 550011 550010 550009 550008 550007 550240 550126 550241. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1585-2023 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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      "@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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