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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Model EPIQ 5 Ultrasound System.

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 Class 2 Recall
Philips Model EPIQ 5 Ultrasound System.
see related information
Date Posted March 20, 2014
Recall Status1 Open
Recall Number Z-1263-2014
Recall Event ID 67685
Premarket Notification
510(K) Number
K132304 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Philips Model EPIQ 5 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, Washington 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 by
FDA Determined
Cause 2
DESIGN: 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 489 total =227 units in US and 262 units Internationally (no Canadian consignees)
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = PHILIPS ULTRASOUND, INC.
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