{ "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": "2026-04-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Laurel", "state": "MD", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "68067", "recalling_firm": "GE Healthcare", "address_1": "8880 Gorman Rd", "address_2": "N/A", "postal_code": "20723-5800", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution.", "recall_number": "Z-1548-2014", "product_description": "Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).", "product_quantity": "723 units", "reason_for_recall": "Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.", "recall_initiation_date": "20140402", "center_classification_date": "20140506", "termination_date": "20160511", "report_date": "20140514", "code_info": "HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705 HDJR57706 HDJR57707 HDJR57784 HDJR57785 HDJR57786 HDJR57787 HDJR57788 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