{ "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": "131545", "product_res_number": "Z-0817-2015", "event_date_initiated": "2014-11-05", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2016-08-15", "res_event_number": "69790", "product_code": "IYN", "k_numbers": [ "K132304" ], "product_description": "EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721.\n\nDiagnostic Ultrasound Imaging.", "code_info": "SERIAL NUMBERS FOR FCO 079500318- EPIQ 7 SYSTEM:  US114B0038, US114B0040, US114B0055, US114B0091, US114B0111, US114B0112, US114B0113, US114B0114, US114B0115, US114B0125, US114B0128, US114B0129, US114B0161, US114B0185, US114B0186, US114B0201, US114B0204, US114B0225, US114B0235, US114B0236, US114B0266, US114B0267, US114B0307, US114B0335, US114B0336, US114B0337, US114B0355, US114B0358, US114B0359, US114B0360, US114B0398, US114B0399, US114B0400, US114B0401, US114B0471, US114B0473, US114B0474, US114B0478, US114B0493, US114B0494, US114B0495, US114B0508, US114B0510, US114B0511, US114B0527, US114B0528, US114B0529, US114B0530, US114B0572, US114B0579, US114B0580, US114B0581, US114B0582, US114B0596, US114B0599, US114B0600, US114B0601, US114B0602, US114B0603, US114B0604, US114B0608, US114B0615, US114B0620, US114B0621, US114B0622, US114B0650, US114B0651, 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US913B0400, US913B0401, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0504, US913B0505, US913B0506, US913B0522, US913B0566, US913B0567, US913B0614, US913B0615, US913B0616, USD13B0017, USD13B0056, USD13B0057, USD13B0058, USD13B0059, USD13B0060, USD13B0063, USD13B0076, USD13B0077, USD13B0078, USD13B0079, USD13B0080, USD13B0081, USD13B0082, USD13B0083, USD13B0084, USD13B0085, USD13B0119, USD13B0147, USD13B0148, USD13B0154, USD13B0243, USD13B0244, USD13B0247, USD13B0248, USD13B0249, USD13B0250, USD13B0251, USD13B0300, USD13B0301, USD13B0302, USD13B0303, USD13B0304, USD13B0305, USD13B0306, USD13B0307, USD13B0308, USD13B0309, USD13B0310, USD13B0349, USD13B0353, USD13B0354, USD13B0355, USD13B0356, USD13B0378, USD13B0379, USD13B0381, USD13B0382, USD13B0415, USD13B0416, USD13B0423, USD13B0435, USD13B0436, USD13B0437, USD13B0438, USD13B0466, USD13B0467, USD13B0468, USD13B0489, USD13B0498, USD13B0514, USD13B0533, USD13B0534, USD13B0535, USD13B0547, USD13B0548, USD13B0549, USD13B0551, USD13B0561, USD13B0565, USD13B0566, USD13B0567, USD13B0576, USD13B0577, USD13B0578, USD13B0579, USD13B0580, USD13B0581, USD13B0582, USD13B0634, USD13B0635, USD13B0636, USD13B0640, USD13B0641, USD13B0645, USD13B0646, USD13B0647, USD13B0648, USD13B0649, USD13B0659, USD13B0664, USD13B0665, USD13B0666, USD13B0673, USD13B0674, USD13B0675, USD13B0676, USD13B0701, USD13B0702, USD13B0704, USD13B0706, USD13B0721, USD13B0775, USD13B0777, USD13B0778, USD13B0780, USD13B0785, USN13B0033, USN13B0036, USN13B0153, USN13B0154, USN13B0155, USN13B0159, USN13B0202, USN13B0203, USN13B0233, USN13B0234, USN13B0308, USN13B0333, USN13B0334, USN13B0348, USN13B0419, USN13B0420, USN13B0433, USN13B0434, USN13B0435, USN13B0436, USN13B0438, USN13B0439, USN13B0440, USN13B0464, USN13B0465, USN13B0506, USN13B0507, USN13B0510, USN13B0511, USN13B0512, USN13B0513, USN13B0514, USN13B0515, USN13B0558, USN13B0562, USN13B0563, USN13B0565, USN13B0587, USN13B0589, USN13B0590, USN13B0591, USN13B0592, USN13B0643, USN13B0650, USO13B0043, USO13B0206, USO13B0211, USO13B0213, USO13B0214, USO13B0242, USO13B0243, USO13B0244, USO13B0264, USO13B0265, USO13B0267, USO13B0287, USO13B0293, USO13B0297, USO13B0304, USO13B0311, USO13B0322, USO13B0323, USO13B0325, USO13B0326, USO13B0328, USO13B0329, USO13B0330, USO13B0331, USO13B0332, USO13B0393, USO13B0394, USO13B0441, USO13B0442, USO13B0450, USO13B0451, USO13B0452, USO13B0509, USO13B0510, USO13B0511, USO13B0512, USO13B0549, USO13B0554, USO13B0560, USO13B0561, USO13B0562, USO13B0563, USO13B0608, USO13B0609, USO13B0632, USO13B0633, USO13B0635, USO13B0643, USO13B0673, and USO13B0677.", "firm_fei_number": "3019216", "recalling_firm": "Philips Ultrasound, Inc.", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Customer Service\n425-482-8466", "reason_for_recall": "When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV and EF calculated by manual tracing without the use of QLAB. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy.", "root_cause_description": "Software design", "action": "Philips has identified additional affected units and sent the Urgent-Field Safety Notice -Philips Ultrasound QLAB 10.0 (on Xcelera) letter, dated 2015/3/17, to their consignees. The FCO associated with this letter is FSN MA-FCO 83000190.\n\nThe affected units identified as QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. QLAB software installed on Philips diagnostic ultrasound systems (carts) is the subject of a separate Field Safety Notice (FSN MA-FCO79500316 ).\n\nPhilips has corrected this issue with QLAB version 10.2 on Xcelera and will contact customers to arrange installation of the upgrade to version 10.2 or higher free of charge.\n\nIf consignees need any further information or support concerning the FCO 83000190, please contact your local Philips representative or Philips Customer Service at 1-800-722-9377.\n\n***************************************************************************************\n\nPhilips has begun sending out the URGENT - Medical Device Correction letters, dated 2014 NOV 05, for the Philips Ultrasound QLAB, Philips Model EPIQ 5 Ultrasound System, Philips Model EPIQ 7 Ultrasound System, and Philips Ultrasound Q-Station.\n\nThe customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321.\n\n\nThe letters notified customers that Erroneous End-Systolic Volumes and Ejection Fraction May Be Reported When Using a2DQ & aCMQ (Auto 2D Quantification & Auto Cardiac Motion Quantification).\n\nCustomers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.", "product_quantity": "701 units (237 in the US and 464 outside US)", "distribution_pattern": "Worldwide distribution (for FCO 83000190): US, including the states of AK, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, and WI; and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Germany, Ecuador, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, Norway, New Zealand, Philippines, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, and Vietnam. \n\n**********************************************************************************\nWorldwide Distribution -- US, including the states of KY, TN, ME, CA, PA, NC, CT, NY, SC, IL, IN, and WI; and the countries of Argentina, Spain, India, Italy, Austria, Germany, Belgium, Canada, Finland, Switzerland, Greece, Malaysia, Sweden, Australia, Netherlands, Mexico, Peru, Taiwan, Japan, France, and Norway.", "openfda": { "k_number": [ "K152309", "K891238", "K062247", "K141261", "K152195", "K180374", "K152165", "K162187", "K840953", "K103649", "K040596", "K253716", "K133431", "K181637", "K001711", "K090229", "K052042", "K172129", "K162549", "K123610", "K150002", "K073408", "K112122", "K242223", "K143089", "K171048", "K253597", "K802254", "K130801", "K173957", "K173486", "K251985", "K101312", "K200708", "K101878", "K153421", "K091009", "K010631", "K053084", "K813544", "K033139", "K200449", "K160807", "K241201", "K113690", "K211746", "K992663", "K152543", "K233195", "K840402", "K222198", 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