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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostic Ultrasound System Ultrasound Pulsed Doppler Imaging

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  Class 2 Device Recall Diagnostic Ultrasound System Ultrasound Pulsed Doppler Imaging see related information
Date Initiated by Firm December 16, 2020
Create Date February 02, 2021
Recall Status1 Terminated 3 on March 15, 2023
Recall Number Z-0944-2021
Recall Event ID 87012
510(K)Number K182857  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi.

MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA

MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA

MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA

MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA
Code Information All EPIQ Systems with software version 7.0 Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi 
Recalling Firm/
Manufacturer		 Philips Ultrasound Inc
22100 Bothell Everett Hwy
Bothell WA 98021-8431
Manufacturer Reason
for Recall		 The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 12/16/2020, the manufacturer sent an Urgent Medical Device Correction letter (MDC) with instructions on how to turn off the Image Boost feature. Philips will resolve the issue by providing a software update, at no cost, to correct all affected EPIQ Ultrasound Systems (the update will disable the Image Boost feature when connected to an X8-2t TEE Transducer). Method of Notification - Letter (Urgent Medical Device Correction Letter in the US, Field Safety Notice in rest of the world, Distributor Letter in rest of the world). For US customers, the letters will be sent via certify mail with electronic return receipt. Philips Markets Organizations are responsible for distributing the letters outside of the US.
Quantity in Commerce 607 units
Distribution US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Latvia, Lithuania, Malta, Mexico, Netherlands, Norway, Poland, Romania, Russia, Senegal, Slovenia, Sri Lanka, South Africa, Switzerland, Thailand, Turkey, UAE 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.
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