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Philips Ultrasound Inc recalls EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Recalled August 25, 2021 · FDA recall Z-2306-2021 · Philips Ultrasound
Hazard
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 Class II
Units
8935
Sold at
Worldwide 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.
Description
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.
Product
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Manufacturer(s)
Philips Ultrasound Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →