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RecallWatchMedical Device Safety
Class IICompletedZ-1007-2026

Philips Ultrasound, LLC recalls Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c tr…

Philips Ultrasound, LLCBothell, WA, United StatesReported Jan 7, 2026 · 6 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer7 codes
  • 795200
  • 795201
  • 795231
  • 795232
  • 795234
  • 795117
  • 795122

Lot / code information

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

What the firm is doing

On July 18, 2022, Phillips issued a product notification to affected consignees. Philips ask consignees to take the following actions: 1. If the X5-1c transducer is connected to the right-most port (when viewing from the front), this problem will not occur. Please ensure your X5-1c is connected to the right-most connector until the software update (FCO79500561) has been installed. 2. Please retain this letter with your product documentation until the software update (FCO79500561) has been implemented on your system. 3. Please circulate this notice to all users of this device so that they are aware of the issue. 4. A Philips Field Service Engineer will contact you to schedule the installation of the software update to resolve this issue (reference FCO79500561).

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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