Z-2306-2021 Class II

Recalled by Philips Ultrasound Inc — Bothell, WA

Recall Details

Product Type
Devices
Report Date
August 25, 2021
Initiation Date
July 22, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8935

Product Description

EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

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.

Distribution Pattern

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.

Code Information

Manufactured Between 2020-02-27 to 2021-05-25