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  "name": "GS70H Salus Surgical Table, Product Code 18-071-70",
  "description": "FDA recall Z-2470-2023 — Skytron, LLC is recalling GS70H Salus Surgical Table, Product Code 18-071-70 (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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    "name": "GS70H Salus Surgical Table, Product Code 18-071-70",
    "manufacturer": {
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      "name": "FDA recall Z-2470-2023: Skytron, LLC is recalling GS70H Salus Surgical Table, Product Code 18-071-70",
      "text": "The FDA logged enforcement record Z-2470-2023: Skytron, LLC is voluntarily recalling GS70H Salus Surgical Table, Product Code 18-071-70 — reason: When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control.    Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-01. Affected lots/codes: Serial Numbers:SUC-20207-0002 SUC-20208-0006 SUC-20209-0010 SUC-2020X-0014 SUC-2022Z-0018 SUC-20233-0022 SUC-20207-0003 SUC-20208-0007 SUC-20209-0011 SUC-2020X-0015 SUC-2022Z-0019 SUC-20233-0023 SUC-20208-0004 SUC-20209-0008 SUC-2020X-0012 SUC-2020X-0016 SUC-2022Z-0020 SUC-20233-0024 SUC-20208-0005 SUC-20209-0009 SUC-2020X-0013 SUC-2022Z-0017 SUC-2022Z-0021 SUC-20233-0025. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2470-2023/fda-classification",
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      "name": "FDA classified recall Z-2470-2023 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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      "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."
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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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      "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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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control.    Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of  Australia, New Zealand.",
            "Status": "recorded"
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