{ "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": "211206", "product_res_number": "Z-0684-2025", "event_date_initiated": "2024-11-25", "event_date_posted": "2024-12-17", "recall_status": "Open, Classified", "res_event_number": "95786", "product_code": "MWJ", "k_numbers": [ "K211651" ], "product_description": "Eclipse PRO REF 98700\n\nThe Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.", "code_info": "Model Number: 98700\nUDI-DI code: 10841522128851\nSerial Numbers: All serial numbers manufactured between April 2021 to November 2024. Serial Numbers pending.", "firm_fei_number": "3002807992", "recalling_firm": "Spacelabs Healthcare, Ltd.", "address_1": "Unit B Foxholes Centre John Tate Road", "address_2": "Unit B", "city": "Hertford", "country": "United Kingdom", "additional_info_contact": "Zachary Orlowski\n425-396-3300", "reason_for_recall": "Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.", "root_cause_description": "Process control", "action": "On 11/25/2024, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Letter to customers inform them that the Eclipse Pro and Eclipse MINI cardiac Holter monitors may have mismatched serial numbers between the label and what is programmed in the devices. This is due to a manufacturing error.\n\nCustomers are instructed to:\ncomplete the following steps for each Eclipse device under your control.\nFollowing these steps will allow you to check if your device is affected.\n1. Visit https://eclipseutils.cardiology.spacelabs.com/\n2. The first time you use this site you will need to register for an account. Click Register and create a username and password.\n3. Plug Eclipse (Mini or Pro) device into the computer via USB.\n4. Select Serial Check in the menu and click CONNECT NEW RECORDER \n5. Select the device from the list and click Connect \n6. Click VERIFY SERIAL NUMBER once the device is connected\n7. When prompted, enter the serial number printed on the label of the device and click CONTINUE \n8. If the serial number you entered on the website does not match the serial number loaded into the device, you will see the warning. Confirm that you do not have a typo in the serial number you entered on the website. If you have a typo, click GO BACK . If correctly entered the serial number click CONFIRM .\n9. If the serial number entered on the website matches the serial number loaded into the device, you will see the confirmation below. Confirm that you do not have a typo in the serial number you entered on the website. If you have a typo, please click GO BACK . If you have correctly entered the serial number click CONFIRM .\n10. Repeat the previous steps for all your eclipse devices.\n\nQuestions or assistance - contact Spacelabs service at 1-800-522-7025 or visit us at https://spacelabshealthcare.com/support/\n\nFollow-up Updated Customer Letter sent 04/04/2025", "product_quantity": "13,202 devices", "distribution_pattern": "U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI.\n\nO.U.S.:\nArgentina\nDenmark\nKuwait\nSerbia\nAustralia\nDominican Republic\nLebanon\nSingapore\nAustria\nEcuador\nLithuania\nSpain\nBelgium\nEl Salvador\nMartinique\nSweden\nBenin\nFrance\nMexico\nSwitzerland\nBolivia\nGermany\nNetherlands\nTaiwan\nBrazil\nGreece\nOman\nTrinidad and Tobago\nBrunei Darussalam\nGuatemala\nPanama\nTurkey\nCanada\nHonduras\nPeru\nUnited Arab Emirates\nChile\nHong Kong\nPoland\nUnited Kingdom\nChina\nIceland\nPortugal\nColumbia\nIndia\nVenezuela\nCongo\nIreland\nQatar\nViet Nam\nCosta Rica\nIsrael\nRepublic of Macedonia\nCroatia\nItaly\nRoumanie\nCzech Republic\nKorea, Republic of\nSaudi Arabia", "openfda": { "k_number": [ "K061293", "K130294", "K083382", "K992584", "K101969", "K000609", "K042469", "K102723", "K122272", "K161062", "K001288", "K112573", "K212317", "K032882", "K142424", "K051686", "K071011", "K001317", "K021470", "K043010", "K021373", "K032466", "K050731", "K211651", "K070014", "K091054", "K063042", "K130785", "K993617", "K173156", "K011837", "K233864", "K071733", "K152626", "K112601", "K210758", "K001349", "K030856", "K253562", "K993643", "K252839", "K032276", "K062959", "K003520", "K982843", "K101024", "K041901", "K222017", "K073545", "K982975", "K982617", "K133014", "K003707", "K231424", "K992425", "K993618", "K071085", "K031074", "K100266", "K100310", "K253384", "K211709" ], "registration_number": [ "3004006614", "3010222749", "9610816", "3008159616", "3008977358", "3012027770", "3016406615", "1224919", "1000122786", "3004035727", "3035371769", "9611295", "1527715", "3011883032", "3016618143", "3015185344", "3008413470", "3013500228", "2028530", "1316463", "1126271", "3004009431", "3012528160", "3013889955", "1218950", "3016701404", "3017446092", "3010082909", "9681548", "3009443693", "3008717264", "3010844918", "3013596024", "2133641", "3007184699", "3009499478", "3007770164", "3009077524", "3015529350", "3010390468", "3014235520", "3032906215", "3010157426", "3010381606", "3003971136", "3006087789", "3043479346", "1000165971", "3014848734", "3010552191" ], "fei_number": [ "3004006614", "3010222749", "3008159616", "3008977358", "3012027770", "3016406615", "1000263641", "1000122786", "3004035727", "3035371769", "1527715", "3011883032", "3016618143", "1000125122", "3008413470", "3015185344", "3002807745", "3013500228", "1316463", "3004009431", "3000203466", "3012528160", "3002807992", "3013889955", "1218950", "3016701404", "1000513706", "3017446092", "3010082909", "3010844918", "3009443693", "3008717264", "3013596024", "3007184699", "3009499478", "3007770164", "3015191855", "3009077524", "3015529350", "3010390468", "3014235520", "3032906215", "3010157426", "3010381606", "3003971136", "3006087789", "3002807167", "3043479346", "1000165971", "3014848734" ], "device_name": "Electrocardiograph, Ambulatory (Without Analysis)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2800", "device_class": "2" } } ] }