Z-2306-2021Class II

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

Name: Z-2306-2021 EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx...
Creator: Philips Ultrasound Inc
Published: 2021-07-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-07-22 / Completed / root cause: design

FDA source

Philips Ultrasound Inc began a recall of EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi on 2021-07-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2306-2021
Classification: Class II
Status: Completed
Initiated: 2021-07-22
Posted: 2021-08-16
Recalling firm: Philips North America LLC
Product: EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 8935
Distribution: 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.
Product codes and lots: Manufactured Between 2020-02-27 to 2021-05-25

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2306-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2306-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-25	2021-08-16

Product code IYN

K182857Class IIEPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2018-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)