{ "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": "211491", "product_res_number": "Z-0806-2025", "event_date_initiated": "2024-11-18", "event_date_posted": "2025-01-06", "recall_status": "Open, Classified", "res_event_number": "95902", "product_code": "NEU", "k_numbers": [ "K183400" ], "product_description": "EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS\nProduct Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.", "code_info": "Lot Code: All EnVisio Patient Pad Transition Cushions\nREF: ENVISIO-CUSHION", "firm_fei_number": "3014653199", "recalling_firm": "Elucent Medical Inc", "address_1": "7480 Flying Cloud Dr Ste 110 7480 Flying Cloud Dr", "address_2": "Ste 110", "city": "Eden Prairie", "state": "MN", "postal_code": "55344-3720", "additional_info_contact": "Judson Guericke\n651-7288855", "reason_for_recall": "There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.", "root_cause_description": "Device Design", "action": "An \"Urgent Medical Device Recall\" letter dated 11/18/24 was sent to customers.\n\nHow to Recognize That the Device May Fail:\nAn audible sound is made by the compression of the EnVisio Patient Pad Transition Cushion prior to the back section disassociation from the bed frame. We are aware of one product event associated with one complaint involving this issue.\n\nComponent Which is the Subject of This Recall:\nThe subject of this recall is the EnVisio Patient Pad Transition Cushion as it pertains to the inclining of Skytron Beds greater than 40 degrees.\n\nActions to be Taken by the Customer:\nDue to potential harm resulting from the back section disassociating from the bed frame of Skytron beds, Elucent Medical is recommending not inclining Skytron beds beyond 40 degrees with the EnVisio Patient Pad Transition Cushion present. The Patient Pad Transition Cushion can be used safely when the bed itself is not inclined to such a degree.\n\nElucent is working on an engineering solution that will allow increased range of incline of Skytron model beds. A replacement Patient Pad Transition Cushion will be provided to you as soon as possible.\n\nActions to be Taken by Elucent Medical:\nElucent Medical will replace all Patient Pad Transition Cushions as soon as a suitable replacement is tested and available.\n\nContact Information\nPlease address all specific questions regarding this recall to Elucent Customer Service via telephone (844-417-1700) [Monday Friday, 7:00am 5:00 pm Central Time] or email (customerservice@elucent.com).", "product_quantity": "283 (48 units)", "distribution_pattern": "US Distribution: AZ, CA, CO, CT, FL, GA, IL, KY, MN, NC, ND, NJ, NY, OH, PA, SC, WI", "openfda": { "k_number": [ "K093064", "K183503", "K072216", "K240429", "K010348", "K143484", "K232615", "K133697", "K233639", "K223107", "K180061", "K240527", "K161021", "K251989", "K090547", "K193189", "K192771", "K232865", "K241762", "K062528", "K210752", "K093473", "K042341", "K130537", "K070436", "K190932", "K170803", "K050090", "K151998", "K130763", "K231579", "K253761", "K132708", "K182082", "K072913", "K201863", "K212882", "K081085", "K063238", "K081170", "K090581", "K102506", "K192371", "K180640", "K013413", "K051421", "K033447", "K251748", "K083006", "K230836", "K132463", "K073095", "K181007", "K181692", "K023694", "K060769", "K234149", "K020276", "K240042", "K023450", "K080698", "K171767", "K082278", "K040990", "K102768", "K190689", "K042296", "K053518", "K203097", "K012955", "K072219", "K152510", "K123911", "K212158", "K100994", "K142198", "K173587", "K113202", "K121113", "K141722", "K180443", "K153189", "K090501", "K170905", "K210600", "K141356", "K102608", "K221961", "K014148", "K140835", "K063193", "K180621", "K152586", "K050384", "K131654", "K252892", "K040706", "K243642", "K103417", "K183400", "K011856", "K222832", "K170026", "K111895", "K111692", "K031938", "K121964", "K231468", "K152070", "K253888" ], "registration_number": [ "1020279", "3009192245", "1222140", "3009656988", "3012644426", "2029275", "3009905888", "1835568", "3015542154", "3006950086", "2135401", "3009649442", "1825034", "3015924373", "3016678045", "3021179744", "1222780", "3013012623", "3005160949", "3009077524", "3011245468", "3004636440", "3005636544", "3014967969", "1625425", "3007200016", "2936485", "1226183", "3026851515", "2032338", "3018094310", "3030927217", "1644312", "3010813819", "1647149", "3011162972", "1211566", "1000486410", "3018024590", "3004111573", "3015309643", "1319660", "3007185216", "3007738736", "1064858", "3007055279", "3009609358", "1220477", "1724474", "1450662", "3008492462", "3008992312", "3008627763", "3013649990", "3030733800", "3014090621", "1054811", "3038503932", "3004904811", "2134494", "3000126629", "3002907620", "3011683674", "1721504", "1721676", "2020394", "2951215", "3020733550", "9680340", "3013557562", "1000393132", "3009039068", "3021008900", "3007366790", "3008706707", "1018233", "3019807891", "3033589330", "9617429", "3012536737", "3006981798", "1037905", "3015439135", "3014680735", "3036009309", "3006082230", "1417485", "3007305589", "3015225571", "3012345110", "2022435", "3014653199", "1928237", "2183744", "3033536844", "3013176080", "3013875526", "3035366890", "3010083866", "3010339638", "3015207155", "3014579161", "3008236846" ], "fei_number": [ "1020279", "3009192245", "3009656988", "3012644426", "3001237677", "3009905888", "3015542154", "3006950086", "3009649442", "1825034", "3015924373", "3016678045", "3021179744", "3013012623", "3005160949", "3009077524", "1000121130", "3011245468", "3004636440", "3005636544", "1000221492", "3014967969", "1625425", "3007200016", "3007282753", "2936485", "3026851515", "3018094310", "3030927217", "3003367650", "3010813819", "3011162972", "3008397795", "1000486410", "1000306431", "1211566", "3018024590", "3004111573", "3015309643", "3007185216", "3007738736", "3007055279", "3009609358", "3003295907", "1220477", "1450662", "3008492462", "3008992312", "3008627763", "3013649990", "1000136478", "1000434163", "3030733800", "3014090621", "3038503932", "3002757549", "3004904811", "1000114185", "3000126629", "3002907620", "3011683674", "1721504", "1721676", "3002807584", "2020394", "3020733550", "1000393132", "3013557562", "3009039068", "3021008900", "3008706707", "1000117748", "1018233", "3019807891", "3033589330", "3012536737", "3006981798", "1037905", "3015439135", "3002619738", "3014680735", "3036009309", "3006082230", "1417485", "3007305589", "3015225571", "3012345110", "2022435", "3014653199", "3003094851", "1928237", "2183744", "1000306139", "1000120743", "3033536844", "3013176080", "3013875526", "3035366890", "3010083866", "3010339638", "3015207155", "3014579161", "3008236846" ], "device_name": "Marker, Radiographic, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }