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U.S. Department of Health and Human Services

Class 2 Device Recall EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EP

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 Class 2 Device Recall EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPsee related information
Date Initiated by FirmJuly 22, 2021
Create DateAugust 16, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2306-2021
Recall Event ID 88313
510(K)NumberK182857 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductEPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Code Information Manufactured Between 2020-02-27 to 2021-05-25
Recalling Firm/
Manufacturer		 Philips Ultrasound Inc
22100 Bothell Everett Hwy
Bothell WA 98021-8431
Manufacturer Reason
for Recall		Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.
FDA Determined
Cause 2		Device Design
ActionMedical device correction notices were mailed to customers who were asked to take the following actions to prevent risks for patients or users: When Positioning or Transporting/Moving the EPIQ Ultrasound System: A) Prior to positioning or transporting/moving the system, ensure the control panel locking mechanism is engaged to prevent the control panel and monitor from swiveling freely. B) To ensure the control panel locking mechanism is working properly: 1. Engage the system brake. 2. Observe the lock/unlock button on the system handle. It should not be illuminated. 3. If it is illuminated press button to lock arm. Illumination should cease and arm should lock. 4. Using the system handle, attempt to rotate the control panel. If the control panel does not rotate, the system is locked and ready to be transported/moved. 5. Release the brake and transport/move the system as needed. C) Do not make any twisting or sudden motions with the control panel when adjusting or steering the system. D) When transporting/moving the system, push from behind using the back handles on the control panel. Additional information can be obtained from your local service representative: 1-800-722-9377 Complete and return the response form.
Quantity in Commerce8935
DistributionWorldwide distribution - US Nationwide distribution including in the states of FL, UT, CA, CO, WA, MS, NC, NV, GA, LA, VA, SC, NE, TN, HI, OR, ID, MI, OH, IN, IL, OK, TX, PA, NJ, CT, NY, DE, SD, WI, VT, MN, KS, MO, KY, MA, NH, IA, MT, NM, ME, AZ, AR, AL, WY, ND, AK, MD, RI, WV, DC, VI and the countries of Argentina, Australia, Bahrain, Peru, Serbia, Bolivia, Moldova, Albania, Ukraine, Uruguay, Belarus, Hungary, Greece, Honduras, Montenegro, Senegal, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Dominican Republic, Germany, Ecuador, Estonia, Finland, Taiwan, Georgia, United Kingdom, Guatemala, Hong Kong, Indonesia, Iran, Israel, Yemen, Jordan, Korea, Republic of, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Morocco, Mauritius, Nicaragua, New Zealand, Norway, Oman, United Arab Emirates, Austria, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Thailand, Czech Republic, Tunisia, Uzbekistan, South Africa, Sweden, Switzerland, Netherlands, France, Monaco, Martinique, New Caledonia, Italy, China, India, Denmark, Singapore, Belgium, Spain, Mexico, Viet Nam, Philippines, Malaysia, Japan, Bangladesh, Ireland, Luxembourg, Andorra, Nepal, Myanmar, Pakistan, Brunei Darussalam, French Guiana, Sri Lanka, Kazakhstan, Egypt, Turkey, Kuwait, Romania, Slovakia, Croatia, Slovenia, Bosnia and Herzegovina.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYN
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