{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1150-2026.jsonld", "@type": "schema:Dataset", "name": "Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No", "description": "FDA recall Z-1150-2026 — Edan Diagnostics is recalling Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No (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.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1150-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No", "manufacturer": { "@type": "schema:Organization", "name": "Edan Diagnostics" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1150-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1150-2026: Edan Diagnostics is recalling Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No", "text": "The FDA logged enforcement record Z-1150-2026: Edan Diagnostics is voluntarily recalling Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No — reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-24. Affected lots/codes: EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "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-1150-2026&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-1150-2026&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-1150-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1150-2026 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", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1150-2026&lang=eng", "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-1150-2026&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-1150-2026/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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1150-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1150-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Edan Diagnostics", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-10-24", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "EDAN Model: MFM-CMS UDI-DI code: 06944413800229 Serial/Lot Numbers: 261432-M18312480001 261432-M18803430001 261432-M18B04070001 261432-M18B04070002 261432-M18C06730001 261432-M18C06730002 261432-M18C06730004 261432-M18C06730003 261432-M18C06730005 261432-M18C06730006 261432-M19402160001 261432-M19402160003 261432-M19402160002 261432-M19B02530001 261432-M19B02530006 261432-M19A10370007 261432-M19B02530005 261432-M19B02530003 261432-M19B02530002 261432-M20213550006 261432-M20213550005 261432-M20213550003 261432-M20213550002 261432-M20213550004 261432-M20213550001 261432-M20702060001 261432-M20702060006 261432-M20702060002 261432-M20702060004 261432-M20702060007 261432-M20702060005 261432-M20708340003 261432-M20708340005 261432-M20708340002 261432-M20708340004 261432-M20708340001 261432-M20708340006 261432-M20810650003 261432-M20810650004 261432-M20810650002 261432-M20810650001 261432-M20810650006 261432-M20810650005 261432-M18401960001 261432-M20C04930001 261432-M20C04930002 261432-M20C04930005 261432-M20C04930004 261432-M20C04930003 261432-M20C04930006 261432-M21111490005 261432-M21111490004 261432-M21111490003 261432-M21111490002 261432-M21111490006 261432-M21111490001 261432-M21206490002 261432-M21206490006 261432-M21206490001 261432-M21206490005 261432-M21206490004 261432-M21206490003 261432-M21409870005 261432-M21409870003 261432-M21409870004 261432-M21409870001 261432-M21409870002 261432-M21409870006 261432-M21509140001 261432-M21509140003 261432-M21509140005 261432-M21509140004 261432-M21509140006 261432-M21509140002 261432-M21706970007 261432-M21706970008 261432-M21706970005 261432-M21706970001 261432-M21706970004 261432-M21706970006 261432-M21809930002 261432-M21909020003 261432-M21909020004 261432-M21909020002 261432-M21810820020 261432-M21810820006 261432-M21810820003 261432-M21809930005 261432-M21809930004 261432-M21809930003 261432-M21809930001 261432-M21909020001 261432-M18400410002 261432-M18310890001 261432-M18501600001 261432-M18802330001 261432-M19912390001 261432-M20412240001 261432-M20708340007 261432-M20915430001 261432-M20B09110001 261432-M20B13840001 261432-M20C10170001 261432-M21204410002 261432-M21204410003 261432-M21204410004 261432-M21204410001 261432-M21306400002 261432-M21306400003 261432-M21306400001 261432-M21316340001 261432-M21404840001 261432-M21512920002 261432-M21512920001 261432-M21615470001 261432-M21702760001 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2330484 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 114M2370760 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1629 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 267M23B1625 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 114M23B0232 EDAN Model: MFM-CMS UDI-DI code: 06944413814264 Serial/Lot Numbers: 262237-M24611330012 262237-M24611330001 262237-M24611330011 262237-M24611330014 262237-M24611330009 262237-M24611330019 262237-M24611330004 262237-M24611330008 262237-M24611330007 262237-M24611330017 262237-M24611330010 262237-M24611330003 262237-M24611330005 262237-M24611330015 262237-M24611330013 262237-M24611330018 262237-M24611330002 262237-M24611330006 262237-M24611330016 262237-M24814380001 262237-M24905030001 262237-M24C17400001 262237-M24C17400003 262237-M24C17400004 262237-M24C17400002 262237-M24C17400005 MRM-CMSIII 262237-M24B06940008 262237-M24B06940001 262237-M24B06940003 262237-M24B06940005 262237-M24B06940010 262237-M24B06940004 262237-M24B06940007 262237-M24B06940006 262237-M24B06940002 262237-M24B06940009", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.", "Status": "recorded" } } ] } ] }