{
  "leg": "device",
  "source": "openFDA (FDA)",
  "source_url": "https://open.fda.gov",
  "query": "dreamstation cpap",
  "total": 2,
  "open_count": 2,
  "class_i_count": 2,
  "records": [
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "DreamStation Auto CPAP. Non-Continuous Ventilator.",
      "reason": "Devices may possess a programming error resulting in an incorrect device configuration.",
      "date": "2025-08-20",
      "recall_number": "Z-2227-2025",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-2227-2025"
    },
    {
      "kind": "enforcement",
      "classification": "Class I",
      "status": "Ongoing",
      "firm": "Philips Respironics, Inc.",
      "product": "Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.  Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.",
      "reason": "A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.",
      "date": "2023-04-12",
      "recall_number": "Z-1322-2023",
      "voluntary": "Voluntary: Firm initiated",
      "distribution": "US Nationwide. France, Reunion.",
      "url": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=detail&recallNumber=Z-1322-2023"
    }
  ],
  "api_urls": [
    "https://api.fda.gov/device/enforcement.json?search=product_description:%22dreamstation%22+AND+product_description:%22cpap%22&sort=report_date:desc&limit=30",
    "https://api.fda.gov/device/recall.json?search=product_res_name:%22dreamstation%22+AND+product_res_name:%22cpap%22&sort=event_date_initiated:desc&limit=30"
  ],
  "contradiction": {
    "sellerClaim": "“Works great, never had any issues, definitely not recalled.”",
    "officialRecord": "FDA records show 2 recall/enforcement records matching this model — including 2 Class I (most serious). Most recent: Class I — Devices may possess a programming error resulting in an incorrect device configuration. (2025-08-20, Philips Respironics, Inc.).",
    "verdict": "conflict"
  },
  "disclaimer": "Informational only — not medical advice and not a safety determination. This reports recall/enforcement records in the openFDA database matching the model name you entered. It does not confirm that a specific used unit is or is not affected — recalls apply to specific model numbers, lots, and serial/date ranges. Always verify your exact model and serial number against the official FDA notice linked here and the manufacturer before using or buying a used medical device."
}