{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86920", "product_res_number": "Z-0567-2010", "event_date_initiated": "2009-10-01", "event_date_posted": "2009-12-23", "recall_status": "Terminated", "event_date_terminated": "2012-06-18", "res_event_number": "53952", "product_code": "CAW", "k_numbers": [ "K013931" ], "product_description": "SeQual Technologies Inc. Eclipse Oxygen System, Model 1000\t\n\nIndicated for the administration of supplemental oxygen.", "code_info": "Serial Numbers: All Serial Numbers affected for units manufactured June 2006 - January 2008.", "firm_fei_number": "1000519984", "recalling_firm": "Sequal Technologies Inc", "address_1": "11436 Sorrento Valley Rd", "city": "San Diego", "state": "CA", "postal_code": "92121", "additional_info_contact": "858-202-3100", "reason_for_recall": "Unit may shut down when operating from the Power Cartridge. A temporary power interruption would cause the unit to sound an alarm and shut down. If the patient does not have access to an alternate supply of oxygen or access to AC or DC power, this may lead to shortness of breath, hypoxia, or in some patients may cause serious health consequences.", "root_cause_description": "Pending", "action": "The recall notification was initiated on November 12, 2009 with the firm forwarding a \"Medical Device Correction\" letter to all of the affected consignees via US Postal Service for US Consignees and FedEx for Foreign Consignees. \n\nThe Medical Device Correction Letter contained the following:\n(1) Medical Device Correction Letter; (2) List of Serial Number affected that were distributed to the Provider; (3) Reply Card that the Provider will be requested to send back regarding receipt notification of the Medical Device Correction Letter and confirming that they have the affected product; (4) Additional Medical Device Correction Letters for Providers to distribute to their patients.\n\nThe Medical Device Correction Letter informed the consignees of the reason for recall, the hazard involved and the actions that were required. For further details or information, consignees were instructed to contact SeQual Technical Support at 1-800-826-4610 from 8:00 AM to 5:00 PM PST.", "product_quantity": "6,588 units", "distribution_pattern": "Worldwide Distribution -- Including countries of USA, ARGENTINA, AUSTRIA, BAHAMAS, BERMUDA, CANADA, CHILE, COLUMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, ITALY, ISRAEL,JAPAN, JORDAN, KUWAIT, MALTA, NETHERLANDS, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.", "openfda": { "k_number": [ "K011844", "K904271", "K182454", "K971947", "K833495", "K903608", "K192693", "K131016", "K861435", "K093308", "K792385", "K014301", "K954271", "K043520", "K162433", "K843715", "K134023", "K090007", "K873071", "K251764", "K971964", "K810411", "K861011", "K955549", "K260171", "K213210", "K083163", "K240840", "K791437", "K013931", "K230702", "K831819", "K901712", "K071904", "K884018", "K791043", "K021082", "K091028", 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"3002768081", "3000210616", "3004972304", "3023245116", "3029227324", "3002807637", "1419185", "3008841036", "1924066", "3011191255" ], "device_name": "Generator, Oxygen, Portable", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5440", "device_class": "2" } } ] }