Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
This recall has been completed (originally issued December 31, 2025).
- Company
- Philips Ultrasound, Llc
- Recall Initiated
- July 14, 2022
- Posted
- December 31, 2025
- Recall Number
- Z-1007-2026
- Quantity
- 1,721 systems
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
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.
Lot / Code Info
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
Root Cause
Software Design Change
Action Taken
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).