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  "name": "Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.  Model Number: 7200.01F2",
  "description": "FDA recall Z-0036-2024 — Getinge Usa Sales Inc is recalling Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.  Model Number: 7200.01F2 (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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      "name": "FDA recall Z-0036-2024: Getinge Usa Sales Inc is recalling Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.  Model Number: 7200.01F2",
      "text": "The FDA logged enforcement record Z-0036-2024: Getinge Usa Sales Inc is voluntarily recalling Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.  Model Number: 7200.01F2 — reason: Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-06. Affected lots/codes: UDI Code: 04046768124363  Serial Numbers: 7 10 9 18 16 14 15 17 13 24 21 22 23 20 25 19 26 32 28 29 30 31 27 42 44 45 46 47 48 49 50 51 54 59 60 52 53 56 57 63 67 74 64 68 72 73 65 69 70 71 66 75 77 78 80 81 82 79 89 83 84 85 86 87 88 90 91 93 92 94 95 96 104 105 99 101 100 102 98 106 107 108 97 103 113 111 112 114 115 119 110 116 118 125 127 128 132 129 130 131 123 124 126 138 134 135 137 139 141 142 143 140 154 146 156 145 147 149 148 150 151 155 161 165 166 164 167 169 171 170 157 162 159 158 163 168 172 174 175 178 179 176 177 152 153 180 181 183 185 182 186 193 196 188 195 189 192 194 190 502 503 504 505 506 507 510 508 509 511 512 513 514 516 520 524 523 521 527 518 519 534 535 536 532 533 541 538 539 537 540 544 545 546 547 548 549 553 550 551 554 555 557 558 556 561 563 564 565 566 569 571 572 567 573 581 579 580 583 585 586 587 584 588 589. A RECORDED FDA enforcement action (occurred=true).",
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      "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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            "Value": "Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users",
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