{ "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": "104432", "product_res_number": "Z-0213-2012", "event_date_initiated": "2011-09-23", "event_date_posted": "2011-11-18", "recall_status": "Terminated", "event_date_terminated": "2013-04-09", "res_event_number": "60101", "product_code": "KGI", "k_numbers": [ "K992125" ], "product_description": "DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers.\n\nThe XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It provides BMD (g/cm2), Area (cm2), and BMC (g) values. It compares these values to gender and ethnic matched reference populations and provides T-Score and % young Reference, Z- Score and % age matched, and long term and short term change values. This includes sBMD (mg/cm2). The XR 46 performs soft tissue assessment and provides lean mass, fat mass, percent fat, and total soft tissue values for all scan sites, including Whole Body. The XR 46 includes a Report writer that allows the operator to customize the appearance of their report stand to automate the tedious part of the report. It also allows the user to enter ranges of patient values and the specific statements they want to be printed on their report for each of these ranges. The bone density measurements from the XR 46 can be used as an aid to physicians in determining fracture risk.", "code_info": "Part Number 434A133 - Revs 4.2.0 through 4.3.1  Scanner S/N \tScanner Type 3602\tEclipse 3730\tEclipse 3734\tEclipse 3763\tEclipse 3807\tEclipse 3862\tEclipse 3863\tEclipse 3873\tEclipse 3912\tEclipse 4006\tEclipse 4100\tEclipse 4216\tEclipse 4231\tEclipse 4258\tEclipse 4295\tEclipse 4296\tEclipse 4340\tEclipse 3796\tEclipse  1027\tExcell 1028\tExcell 1073\tExcell 1088\tExcell 1115\tExcell 1117\tExcell 1122\tExcell 1124\tExcell 1142\tExcell 1163\tExcell 1180\tExcell 1187\tExcell 1213\tExcell 1296\tExcell 1307\tExcell 1360\tExcell 1372\tExcell 1383\tExcell 1405\tExcell 1437\tExcell 1446\tExcell 1472\tExcell 1483\tExcell 1496\tExcell 1527\tExcell 1601\tExcell 1605\tExcell 1637\tExcell 1644\tExcell 1658\tExcell 1676\tExcell 1679\tExcell 1685\tExcell 1687\tExcell 1735\tExcell 1741\tExcell 1793\tExcell 1807\tExcell 1819\tExcell 1846\tExcell 1878\tExcell 1931\tExcell 1934\tExcell 1938\tExcell 1954\tExcell 1954\tExcell 1971\tExcell 1998\tExcell 2004\tExcell 2005\tExcell 2016\tExcell 2017\tExcell 2027\tExcell 2029\tExcell 2031\tExcell 2032\tExcell 2033\tExcell 2034\tExcell 2035\tExcell 6782\tXR-36 6914\tXR-36 8501\tXR-36 6960CE\tXR-36 8005\tXR-46 8017\tXR-46 8066\tXR-46 8147\tXR-46 8148\tXR-46 8162\tXR-46 8188\tXR-46 8216\tXR-46 8325\tXR-46 8329\tXR-46 8331\tXR-46 8334\tXR-46 8335\tXR-46 8511\tXR-600 20000\tXR-600 20001\tXR-600 20002\tXR-600 20005\tXR-600 20013\tXR-600 20018\tXR-600 20020\tXR-600 20022\tXR-600 20023\tXR-600 20024\tXR-600 20028\tXR-600 20032\tXR-600 20034\tXR-600 20036\tXR-600 20047\tXR-600 20048\tXR-600 20049\tXR-600 20051\tXR-600 20052\tXR-600 20057\tXR-600 20059\tXR-600 20060\tXR-600 20064\tXR-600 20067\tXR-600 20069\tXR-600 20070\tXR-600 20073\tXR-600 20074\tXR-600 20077\tXR-600 20078\tXR-600 20079\tXR-600 20082\tXR-600 20085\tXR-600 20087\tXR-600 20090\tXR-600 20094\tXR-600 20102\tXR-600 20104\tXR-600 20108\tXR-600 20116\tXR-600 20121\tXR-600 20133\txr-600 20135\tXR-600 20138\tXR-600 20140\tXR-600 8502\tXR-800 8506\tXR-800 8514\tXR-800 8515\tXR-800 8523\tXR-800 8524\tXR-800 8531\tXR-800 8532\tXR-800 8533\tXR-800 8537\tXR-800 8543\tXR-800 8547\tXR-800 8549\tXR-800 8551\tXR-800 8552\tXR-800 8553\tXR-800 8556\tXR-800 8558\tXR-800 8559\tXR-800 8560\tXR-800 8561\tXR-800 8562\tXR-800 8563\tXR-800 8565\tXR-800 8566\tXR-800 8567\tXR-800 8569\tXR-800 8571\tXR-800 8572\tXR-800 8577\tXR-800 8579\tXR-800 8582\tXR-800 8583\tXR-800 8584\tXR-800 8587\tXR-800 8588\tXR-800 8591\tXR-800 8596\tXR-800 8597\tXR-800 8599\txr-800 8600\txr-800 8604\tXR-800 8611\tXR-800 8614\tXR-800", "firm_fei_number": "1216677", "recalling_firm": "Cooper Surgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "203-601-9825", "reason_for_recall": "The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record.", "root_cause_description": "Software design", "action": "The firm, CooperSurgical, sent a \"Notice of RECALL-URGENT\" letter dated September 23, 1011 to its customers. The letter described the product, \"Problem/Situation\", and \"When can this problem occur?\". CooperSurgical will send a new revision of Illuminatus software to the customers once available.\n\nIf you have any concerns about your existing database of patients, please contact our Norland Technical Support team at (203) 601-5200 Extension 9888 or 9889.", "product_quantity": "184", "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, FL, GA, IN, KS, KY, LA, MD, MA, MI, MO, NJ, NY, NC, OK, PA, TN, TX, UT, and WI ; and countries of: ARGENTINA, AUSTRALIA, BELGIUM SPAIN, CANADA, CHINA, DENMARK, EMIRATES, ENGLAND, FRANCE, GERMANY, GREECE, IRELAND, MALTA, POLAND, SAUDI ARABIA, SOUTH KOREA, and TAIWAN.", "openfda": { "k_number": [ "K964263", "K873296", "K984285", "K121716", "K963363", "K890121", "K961787", "K002500", "K970224", "K852510", "K983269", "K974437", "K945526", "K810140", "K992125", "K844835", "K922286", "K964307", "K864299", "K941126", "K001812", "K901804", "K003656", "K802181", "K905753", "K871553", "K961011", "K902959", "K052581", "K103730", "K980569", "K913078", "K072847", "K992775", "K861515", "K243218", "K000826", "K894795", "K861233", "K881383", "K113616", "K011917", "K000162", "K002711", "K984178", "K071570", "K130277", "K021527", "K993176", "K023398", "K953032", "K973104", "K113725", "K963789", "K931996", "K191112", "K905291", "K033550", "K905691", "K030330", "K792444", "K983271", "K103265", "K934040", "K810159", "K140342", "K220402", "K980125", "K972882", "K871446", "K082402", "K844766", "K113286", "K080711", "K883360", "K220822", "K863618", "K943505", "K941127", "K901848", "K913321", "K180782", "K042480", "K971735", "K992246", "K061561", "K884625", "K983273", "K021331", "K926019", "K904980", "K961007", "K060111", "K113356", "K091325", "K843922", "K041266", "K001756", "K981124", "K002113", "K133664", "K972053", "K941362", "K082317", "K890999", "K952060", "K072439", "K023554", "K901854", "K213760", "K950611", "K161682", "K033224", "K030962", "K973459", "K883280", "K983262", "K841463", "K881865", "K914404", "K242295", "K891582", "K972517", "K915535", "K964562", "K993337", "K982267", "K983564", "K880404", "K926300", "K072664", "K031991", "K252718", "K894854", "K983028", "K961944", "K802180", "K980289", "K896677", "K251022", "K901832", "K992677", "K001429", "K852509", "K901857", "K983724", "K152299" ], "registration_number": [ "3005496266", "3010703925", "3044744649", "3031503890", "3026043045", "3027245002", "9616047", "3010687441", "2939827", "3036666444", "2183066", "9613445", "3019373577", "3008496839", "3008632256", "3004977335", "3015276088", "9616391", "3023003446", "3008921184", "3010208539", "3003600763", "3039211310" ], "fei_number": [ "3005496266", "3010703925", "3044744649", "3031503890", "3026043045", "3027245002", "1000124212", "3010687441", "3036666444", "2183066", "3019373577", "3008496839", "1000646577", "3008632256", "3003377038", "3002175190", "3004977335", "3015276088", "3023003446", "3008921184", "3010208539", "3003600763", "3039211310" ], "device_name": "Densitometer, Bone", "medical_specialty_description": "Radiology", "regulation_number": "892.1170", "device_class": "2" } } ] }