FDA-Device2026-01-07Class IIPROCESSING DEFECT
Philips EPIQ Ultrasound Systems recalled for unexpected automatic reboot risk
What this means
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
The agency's original wording
Hazard
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Intended for
Adults
Illnesses reported
None reported
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-1007-2026Want us to check the next one for you?
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