Class 2 Device Recall Philips Model EPIQ 7 Ultrasound System.

• Date Initiated by Firm: February 28, 2014
• Date Posted: March 20, 2014
• Recall Status: Terminated on December 12, 2016
• Recall Number: Z-1264-2014
• Recall Event ID: 67685
• 510(K)Number: K132304
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.; ; Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206; ; EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
• Code Information: All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014).
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Inc.; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Beth St. Germain; 978-659-4519
• Manufacturer Reason for Recall: A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated b
• FDA Determined Cause: Software design
• Action: The firm, Philips Healthcare Ultrasound, sent an "Medical Device Correction" letters dated 2014 Feb 28 via Certified Mail via the USPS by March 5, 2014. The letters described the product, problem and actions to be taken. The customers were instructed to not use HPRF in PW Doppler mode, to avoid the noted issues. Philips Field Service Engineer will be contacting them to schedule software upgrade to the systems free of charge. If you need any further information or support concerning this issue, please contact the Quality Specialist II at 978-659-4519 or your local Philips representative.
• Quantity in Commerce: 1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada)
• Distribution: Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
• 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.