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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2151-2024.jsonld",
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  "name": "Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses.    (1) Centrella Max Surface, REF P7922A01;  (2) Centrella Max Surface, REF P7922A02;  (3) Centrella Max Surface with X-Ray, REF P7922A03;  (4) Centrella Max,Narrow, Rental, REF P7922ARENT01;  (5) Centrella Pro+ 36\" Surface with X-Ray, REF P7923A01;  (6) Centrella Pro+ 40\" Surface with X-Ray, REF P7923A02;  (7) Centrella Pro+36\" Surface, REF P7923A03;  (8) Centrella Pro+ 40\" Surface, REF P7923A04;  (9)  Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01;  (10) 80\" MRS with X-Ray AU/NZ  REF P006800A03;  (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01;  (12) Pro+ MRS Surface for Versacare, REF P3255A02;  (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01;  (14) Pro+ 36\"MRS Surface with X-Ray, REF  P7924A01;  (15) Pro+ 40\" MRS Surface with X-Ray, REF P7924A02;  (16) Pro+ 36\" MRS Surface, REF  P7924A03;  (17) Pro+ 40\" MRS Surface, REF P7924A04;  (18)  Pro+ 36\" MRS Rental Surface with X-Ray, REF P7924ARENT01.",
  "description": "FDA recall Z-2151-2024 — Baxter Healthcare Corporation is recalling Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses.    (1) Centrella Max Surface, REF P7922A01;  (2) Centrella Max Surface, REF P7922A02;  (3) Centrella Max Surface with X-Ray, REF P7922A03;  (4) Centrella Max,Narrow, Rental, REF P7922ARENT01;  (5) Centrella Pro+ 36\" Surface with X-Ray, REF P7923A01;  (6) Centrella Pro+ 40\" Surface with X-Ray, REF P7923A02;  (7) Centrella Pro+36\" Surface, REF P7923A03;  (8) Centrella Pro+ 40\" Surface, REF P7923A04;  (9)  Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01;  (10) 80\" MRS with X-Ray AU/NZ  REF P006800A03;  (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01;  (12) Pro+ MRS Surface for Versacare, REF P3255A02;  (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01;  (14) Pro+ 36\"MRS Surface with X-Ray, REF  P7924A01;  (15) Pro+ 40\" MRS Surface with X-Ray, REF P7924A02;  (16) Pro+ 36\" MRS Surface, REF  P7924A03;  (17) Pro+ 40\" MRS Surface, REF P7924A04;  (18)  Pro+ 36\" MRS Rental Surface with X-Ray, REF P7924ARENT01. (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2151-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses.    (1) Centrella Max Surface, REF P7922A01;  (2) Centrella Max Surface, REF P7922A02;  (3) Centrella Max Surface with X-Ray, REF P7922A03;  (4) Centrella Max,Narrow, Rental, REF P7922ARENT01;  (5) Centrella Pro+ 36\" Surface with X-Ray, REF P7923A01;  (6) Centrella Pro+ 40\" Surface with X-Ray, REF P7923A02;  (7) Centrella Pro+36\" Surface, REF P7923A03;  (8) Centrella Pro+ 40\" Surface, REF P7923A04;  (9)  Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01;  (10) 80\" MRS with X-Ray AU/NZ  REF P006800A03;  (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01;  (12) Pro+ MRS Surface for Versacare, REF P3255A02;  (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01;  (14) Pro+ 36\"MRS Surface with X-Ray, REF  P7924A01;  (15) Pro+ 40\" MRS Surface with X-Ray, REF P7924A02;  (16) Pro+ 36\" MRS Surface, REF  P7924A03;  (17) Pro+ 40\" MRS Surface, REF P7924A04;  (18)  Pro+ 36\" MRS Rental Surface with X-Ray, REF P7924ARENT01.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Baxter Healthcare Corporation"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2151-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2151-2024: Baxter Healthcare Corporation is recalling Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses.    (1) Centrella Max Surface, REF P7922A01;  (2) Centrella Max Surface, REF P7922A02;  (3) Centrella Max Surface with X-Ray, REF P7922A03;  (4) Centrella Max,Narrow, Rental, REF P7922ARENT01;  (5) Centrella Pro+ 36\" Surface with X-Ray, REF P7923A01;  (6) Centrella Pro+ 40\" Surface with X-Ray, REF P7923A02;  (7) Centrella Pro+36\" Surface, REF P7923A03;  (8) Centrella Pro+ 40\" Surface, REF P7923A04;  (9)  Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01;  (10) 80\" MRS with X-Ray AU/NZ  REF P006800A03;  (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01;  (12) Pro+ MRS Surface for Versacare, REF P3255A02;  (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01;  (14) Pro+ 36\"MRS Surface with X-Ray, REF  P7924A01;  (15) Pro+ 40\" MRS Surface with X-Ray, REF P7924A02;  (16) Pro+ 36\" MRS Surface, REF  P7924A03;  (17) Pro+ 40\" MRS Surface, REF P7924A04;  (18)  Pro+ 36\" MRS Rental Surface with X-Ray, REF P7924ARENT01.",
      "text": "The FDA logged enforcement record Z-2151-2024: Baxter Healthcare Corporation is voluntarily recalling Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses.    (1) Centrella Max Surface, REF P7922A01;  (2) Centrella Max Surface, REF P7922A02;  (3) Centrella Max Surface with X-Ray, REF P7922A03;  (4) Centrella Max,Narrow, Rental, REF P7922ARENT01;  (5) Centrella Pro+ 36\" Surface with X-Ray, REF P7923A01;  (6) Centrella Pro+ 40\" Surface with X-Ray, REF P7923A02;  (7) Centrella Pro+36\" Surface, REF P7923A03;  (8) Centrella Pro+ 40\" Surface, REF P7923A04;  (9)  Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01;  (10) 80\" MRS with X-Ray AU/NZ  REF P006800A03;  (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01;  (12) Pro+ MRS Surface for Versacare, REF P3255A02;  (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01;  (14) Pro+ 36\"MRS Surface with X-Ray, REF  P7924A01;  (15) Pro+ 40\" MRS Surface with X-Ray, REF P7924A02;  (16) Pro+ 36\" MRS Surface, REF  P7924A03;  (17) Pro+ 40\" MRS Surface, REF P7924A04;  (18)  Pro+ 36\" MRS Rental Surface with X-Ray, REF P7924ARENT01. — reason: There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-08. Affected lots/codes: 1.  REF P7922A01 - UDI-DI 887761999084; 2.  REF P7922A02 - UDI-DI 887761999077; 3.  REF P7922A03 - UDI-DI 887761984639; 4.  REF P7922ARENT01 - UDI-DI 887761976962; 5.  REF P7923A01 - UDI-DI 887761977945; 6.  REF P7923A02  UDI-DI 887761977938; 7.  REF P7923A03 UDI-DI 887761977921; 8.  REF P7923A04 UDI-DI 887761977914; 9.  REF P006800A01 - UDI-DI 887761977846; 10. REF P006800A03 - UDI-DI 887761955035; 11. REF P3255A01 - UDI-DI 887761977860; 12. REF P3255A02  UDI-DI 887761977853; 13. REF P3255ARENT01 UDI-DI 887761976887; 14. REF  P7924A01 -UDI-DI 887761977907; 15. REF P7924A02 - UDI-DI 887761977891; 16. REF  P7924A03 - UDI-DI 887761977884; 17. REF P7924A04 - UDI-DI 887761977877; 18. REF P7924ARENT01 - UDI-DI 887761976863.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2151-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2151-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2151-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2151-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
          "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-2151-2024&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-2151-2024/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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      "name": "FDA recall details — Z-2151-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2151-2024",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Baxter Healthcare Corporation",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-08",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1.  REF P7922A01 - UDI-DI 887761999084; 2.  REF P7922A02 - UDI-DI 887761999077; 3.  REF P7922A03 - UDI-DI 887761984639; 4.  REF P7922ARENT01 - UDI-DI 887761976962; 5.  REF P7923A01 - UDI-DI 887761977945; 6.  REF P7923A02  UDI-DI 887761977938; 7.  REF P7923A03 UDI-DI 887761977921; 8.  REF P7923A04 UDI-DI 887761977914; 9.  REF P006800A01 - UDI-DI 887761977846; 10. REF P006800A03 - UDI-DI 887761955035; 11. REF P3255A01 - UDI-DI 887761977860; 12. REF P3255A02  UDI-DI 887761977853; 13. REF P3255ARENT01 UDI-DI 887761976887; 14. REF  P7924A01 -UDI-DI 887761977907; 15. REF P7924A02 - UDI-DI 887761977891; 16. REF  P7924A03 - UDI-DI 887761977884; 17. REF P7924A04 - UDI-DI 887761977877; 18. REF P7924ARENT01 - UDI-DI 887761976863.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution was made nationwide.  There was also government/military distribution.  Foreign distribution was made to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapore, Taiwan, Turkey, and United Arab Emirates.",
            "Status": "recorded"
          }
        }
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