{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "86537", "product_res_number": "Z-0458-2010", "event_date_initiated": "2009-10-23", "event_date_posted": "2009-11-25", "recall_status": "Terminated", "event_date_terminated": "2012-03-29", "res_event_number": "53801", "product_code": "MUD", "k_numbers": [ "K090807" ], "product_description": "Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.", "code_info": "Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926.", "firm_fei_number": "2183646", "recalling_firm": "Nonin Medical, Inc", "address_1": "13700 1st Ave N", "city": "Plymouth", "state": "MN", "postal_code": "55441", "additional_info_contact": "763-553-9968", "reason_for_recall": "A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.", "root_cause_description": "Device Design", "action": "An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166.", "product_quantity": "62", "distribution_pattern": "Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.", "openfda": { "k_number": [ "K133983", "K163070", "K082327", "K241393", "K113656", "K214072", "K042020", "K061619", "K240601", "K141496", "K160526", "K162603", "K182429", "K191676", "K232385", "K112820", "K143219", "K091224", "K123700", "K100875", "K190270", "K181623", "K163472", "K102715", "K012759", "K250519", "K243324", "K094030", "K201976", "K141234", "K093923", "K073656", "K113507", "K233488", "K113215", "K073407", "K100915", "K190334", "K201432", "K153426", "K112826", "K254129", "K103613", "K162117", "K130079", "K051274", "K203490", "K061960", "K042657", "K143675", "K061848", "K230612", "K171245", "K122645", "K182868", "K223651", "K081233", "K190560", "K192322", "K240596", "K023938", "K221010", "K090807", "K133879", "K040684", "K161237", "K211561", "K080769", "K151305", "K053618", "K091452", "K133923", "K180003", "K963903" ], "registration_number": [ "9614683", "2936999", "2183646", "3008729547", "3013679558", "3018094310", "3021343210", "3006161756", "3009906207", "3006082230", "3007137598", "3012359877", "3013436077", "2024311", "3004105270", "3009673645", "8030476", "9710602", "3007616088", "2133641", "3042225166", "3003965364", "3013557562", "3013944123", "9615817", "3011353843", "9610105", "3034456223", "3010611950", "3008717564", "3021337298", "2011171", "3004832480", "1018233", "3018940143", "3013596024", "3037724692", "3013500228", "8020893", "2648045", "3011369688", "2221819", "9610816", "3042025620", "3045891669", "3004415095", "1000314502", "3007603826", "3008058135", "1651104", "3009771004", "3008202779", "3001570235", "3032916632", "3042165671", "8043564", "3009156722", "3004957206" ], "fei_number": [ "2936999", "2183646", "3008729547", "3013679558", "3018094310", "3021343210", "3009906207", "3006082230", "3007137598", "3012359877", "3000203466", "3013436077", "1000601592", "2024311", "3004105270", "3009673645", "3003794634", "3007616088", "1000279065", "3003965364", "3042225166", "3013557562", "3013944123", "3002737156", "3011353843", "3034456223", "3010611950", "3008717564", "3021337298", "3003513129", "2011171", "3004832480", "3002806783", "1018233", "3018940143", "3013596024", "3037724692", "3013500228", "2648045", "3011369688", "2221819", "3003081151", "3042025620", "3045891669", "1000314502", "3002807167", "3008058135", "3004415095", "3007603826", "3009771004", "3008202779", "3002808127", "3032916632", "3001570235", "3042165671", "3009156722", "3004957206", "3002807850" ], "device_name": "Oximeter, Tissue Saturation", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2700", "device_class": "2" } } ] }