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U.S. Department of Health and Human Services

Class 2 Device Recall System, Imaging, Pulsed Doppler, Ultrasonic

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  Class 2 Device Recall System, Imaging, Pulsed Doppler, Ultrasonic see related information
Date Initiated by Firm October 27, 2020
Create Date January 14, 2021
Recall Status1 Terminated 3 on April 19, 2023
Recall Number Z-0864-2021
Recall Event ID 86992
510(K)Number K182857  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System.

MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA
MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA
MOD - EPIQ 100-240V 50/60 Hz, 600 VA
MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA
MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA
MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA
Code Information All EPIQ and Affiniti Ultrasound systems with software versions 1.0, 1.1.x, 1.2.x, 1.3.x, 1.4.x, 1.5.x, 1.8.x, 2.0.x, 3.0.x, 4.0.x, 5.0, 5.0.1
Recalling Firm/
Manufacturer		 Philips Ultrasound Inc
22100 Bothell Everett Hwy
Bothell WA 98021-8431
Manufacturer Reason
for Recall		 The manufacturer has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam. The issue(s) manifest differently for different versions of software.
FDA Determined
Cause 2		 Software design
Action On 10/27/2020,the manufacturer/ recalling firm started sending an Urgent Medical Device Correction letter (MDC) with recommended workflows to prevent the potential issues. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction letter. The effectiveness check will include the delivery confirmation of the Urgent Medical Device Correction Letter in the USA or the Field Safety Notice (FSN) worldwide. In addition, effectiveness checks will be conducted by confirmation that the customer has received the letter and have read/understood the actions documented within (customer reply form).
Quantity in Commerce 57,430 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. The countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Cook Islands, Costa Rica, Corte D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Virgin Islands (British), Virgin Islands (U.S.), Yemen, Zimbabwe.
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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