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FDA-Device2026-01-07Class IIPROCESSING DEFECT

Philips EPIQ Ultrasound Systems recalled for unexpected automatic reboot risk

Philips
OTHERNationwide distribution

Stop using affected Philips EPIQ ultrasound systems

Philips EPIQ Ultrasound Systems with the X5-1c transducer and certain software versions may unexpectedly restart on their own. This automatic reboot can damage the transducer. No injuries have been reported.

  • Check your Philips EPIQ system serial number and software version against the FDA recall notice
  • Stop using the system if it matches the affected models and software versions listed
  • Contact Philips technical support or your equipment representative for instructions on next steps
Hazard

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

Sold states
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.
Affected count
1,721 systems
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Products
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2026

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