Philips Ultrasound, LLC recalls Philips EPIQ Ultrasound Systems

Recalling company

Philips Ultrasound, LLC

Product

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

Reason

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 14, 2022

Reported

Jan 7, 2026

Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of Latvia, Lithuania, Morocco, Netherlands , New Zealand, Oman, Panama, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.

Status

Completed

Quantity

1,721 systems

Lot / codes

Software Version Numbers: 9.0, 9.01, 9.02 795234/UDI: (01)00884838107540 795232/UDI: (01)00884838107533 795231/ UDI: (01)00884838097933 795201/UDI: (01)00884838047693 795200/ UDI: (01)00884838107441 795122/ UDI: (01)00884838097933 795117/ UDI: (01)00884838047693

Company location

Bothell, WA

Recall type

Voluntary: Firm initiated

Recall number

Z-1007-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1007-2026 in the FDA Enforcement Report. Also see FDA recall press releases.