Recall Weekly
Moderate riskFDA DeviceClass II

Philips EPIQ Ultrasound Systems recalled for unexpected automatic reboot risk

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.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
1,721 systems
Illnesses reported
None reported
Manufactured in
22100 Bothell Everett Hwy, N/A, Bothell, WA, United States
Classification
Class II
Recall number
Z-1007-2026

In the FDA's words

Description
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122 Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. 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 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. Affected quantity: 1,721 systems
Hazard
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

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