{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104737", "product_res_number": "Z-0304-2012", "event_date_initiated": "2011-10-12", "event_date_posted": "2011-11-29", "recall_status": "Terminated", "event_date_terminated": "2012-05-30", "res_event_number": "60204", "product_code": "DXN", "k_numbers": [ "K103732" ], "product_description": "Ambulatory Blood Pressure (ABP) Monitor, Model 90217A.\n\nThe Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.", "code_info": "Serial Numbers: 217A-000001, 217A-000013, 217A-000017, 217A-000018, 217A-000019, 217A-000020, 217A-000021, 217A-000022, 217A-000026, 217A-000027, 217A-000028, 217A-000029, 217A-000032, 217A-000033, 217A-000034, 217A-000035, 217A-000036, 217A-000037, 217A-000038, 217A-000039, 217A-000040, 217A-000041, 217A-000042, 217A-000043, 217A-000044, 217A-000045, 217A-000046, 217A-000047, 217A-000048, 217A-000049, 217A-000050, 217A-000051, 217A-000052, 217A-000055, 217A-000056, 217A-000057, 217A-000058, 217A-000059, 217A-000060, 217A-000066, 217A-000068, 217A-000069, 217A-000070, 217A-000071, 217A-000072, 217A-000073, 217A-000074, 217A-000075, 217A-000076, 217A-000077, 217A-000078, 217A-000079, 217A-000080, 217A-000081, 217A-000082, 217A-000083, 217A-000084, 217A-000085, 217A-000086, 217A-000087, 217A-000088, 217A-000089, 217A-000090, 217A-000091, 217A-000092, 217A-000093, 217A-000094, 217A-000095, 217A-000096, 217A-000103, 217A-000104, 217A-000105, 217A-000106, 217A-000107, 217A-000108, 217A-000109, 217A-000110, 217A-000111, 217A-000112, 217A-000113, 217A-000114, 217A-000115, 217A-000116, 217A-000117, 217A-000118, 217A-000119, 217A-000120, 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217A-000878, 217A-000879, 217A-000880, 217A-000902, and 217A-000904.", "firm_fei_number": "3002807992", "recalling_firm": "Del Mar Reynolds Medical, Ltd.", "address_1": "1-2 Harforde Ct., Foxholes 1-2 Harforde Ct. Foxholes Business Park", "city": "Hertford", "country": "United Kingdom", "additional_info_contact": "Spacelabs Healthcare \n800-522-7025 Ext. 2", "reason_for_recall": "If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code.", "root_cause_description": "Device Design", "action": "On October 21, 2011, a Medial Device Correction customer letter was mailed to all US customers. A return receipt was requested.\n\nThe letter identified the affected devices and described the problem. If the device displays an EC75 error code, customers can cycle the power off and then on to restore normal functionality. Please advise patients of this mitigation to avoid a delay in obtaining results. The firm is in the process of upgrading their software to avoid the issue and will contact customers to arrange for an update to their monitors.\n\nCustomers can call Spacelabs Healthcare at 1-800-522-7025, select 2 for Technical support for any question about this recall.", "product_quantity": "785 units worldwide (83 in US and 702 outside US)", "distribution_pattern": "Worldwide Distribution", "openfda": { "k_number": [ "K961144", "K092811", "K242193", "K060315", "K162463", "K830682", "K061557", "K122098", "K161708", "K190134", "K050413", "K061456", "K990338", "K900247", "K000500", "K130564", "K852978", "K896633", "K183058", "K910772", "K853599", "K232621", "K161577", "K133618", "K042273", "K233146", "K190130", "K050040", "K250548", "K112273", "K952979", "K002046", "K251102", "K131749", "K041491", "K840469", "K040371", "K012013", "K253152", "K862756", "K011058", "K113238", "K043186", "K122810", "K081654", "K945111", "K060729", "K101198", "K090768", "K123020", "K210770", "K012035", 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