Class 2 Device Recall EPIQ 5 Ultrasound System, Model: EPIQ 5G, EPIQ 5C, EPIQ 5W

• Date Initiated by Firm: November 05, 2014
• Date Posted: December 16, 2014
• Recall Status: Terminated on August 15, 2016
• Recall Number: Z-0816-2015
• Recall Event ID: 69790
• 510(K)Number: K132304
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541; ; Diagnostic Ultrasound Imaging.
• Code Information: SERIAL NUMBERS FOR FCO 79500317-EPIQ5 system: US114B0005, US114B0006, US114C0193, US114C0209, US114C0239, US114C0240, US114C0241, US114C0271, US114C0272, US114C0273, US114C0284, US114C0286, US114C0287, US114C0308, US114C0331, US114C0334, US114C0366, US114C0751, US214C0043, US214C0106, US214C0140, US214C0143, US214C0144, US214C0416, US214C0417, US314C0199, US314C0298, US314C0447, US314C0728, US314C0745, US314C0800, US314C0801, US414C0012, US414C0066, US414C0114, US414C0157, US414C0158, US414C0159, US414C0395, US514C0081, USD13B0662, USD13C0033, USD13C0234, USD13C0290, USD13C0291, USD13C0481, USD13C0525, USD13C0526, USD13C0527, USD13C0572, USD13C0573, USD13C0584, USD13C0709, USN13B0039, USN13C0018, USN13C0182, USN13C0183, USN13C0184, USN13C0186, USN13C0206, USN13C0281, USN13C0282, USN13C0283, USN13C0284, USN13C0285, USN13C0286, USN13C0312, USN13C0361, USN13C0502, USN13C0503, USN13C0580, USN13C0654, USO13C0352, USO13C0354, USO13C0355, USO13C0356, USO13C0368, USO13C0369, USO13C0395, USO13C0396, USO13C0397, USO13C0398, USO13C0405, USO13C0453, USO13C0454, USO13C0596, USO13C0678, and USO13C0685.
• Recalling Firm/ Manufacturer: Philips Ultrasound, Inc.; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Customer Service; 425-482-8466
• Manufacturer 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.
• FDA Determined Cause: 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. The 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 ). Philips 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. If 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. *************************************************************************************** Philips 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. The customer letter is also identified with the FSN # 79500316; 79500317; 79500318; or 79500321. The 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). Customers with questions should contact local Philips representative or Philips Customer Service at 1-866-767-7822.
• Quantity in Commerce: 88 units (42 in the US and 46 outside US)
• Distribution: 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. ********************************************************************************** Worldwide 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = PHILIPS ULTRASOUND, INC.