—#188369

Product

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

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K182857
Affected lot / code info: Manufactured Between 2020-02-27 to 2021-05-25

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Medical 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.

Recalling firm

Firm: Philips Ultrasound Inc
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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.

Timeline

Recall initiated: 2021-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188369. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.