{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Jerusalem", "state": "", "country": "Israel", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "80895", "recalling_firm": "Oridion Medical 1987 Ltd.", "address_1": "Har Hotzvim Industrial Park Box 45025", "address_2": "Har Hotzvim Industrial Park", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.", "recall_number": "Z-0028-2019", "product_description": "Capnostream20 (US) M, Part Number CS08653", "product_quantity": "769", "reason_for_recall": "The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.", "recall_initiation_date": "20180731", "center_classification_date": "20181003", "termination_date": "20220920", "report_date": "20181010", "code_info": "B300001095 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