{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Wayne", "state": "NJ", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "79340", "recalling_firm": "GETINGE US SALES LLC", "address_1": "45 Barbour Pond Dr", "address_2": "N/A", "postal_code": "07470-2094", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "U.S. and Gov. accts.", "recall_number": "Z-1927-2018", "product_description": "ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094", "product_quantity": "667", "reason_for_recall": "Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.", "recall_initiation_date": "20171116", "center_classification_date": "20180523", "termination_date": "20210721", "report_date": "20180530", "code_info": "Serial Nos. 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