Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Check against the official notice below — it lists the full affected range.
Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with X5-1c transducers due to a software issue affecting versions 9.0, 9.01, and 9.02. The systems may unexpectedly reboot automatically, which can result in damage to the transducer. The affected systems have been distributed worldwide, including throughout all U.S. states and multiple countries including Canada, Australia, and various European nations.
The recall notice does not specify a remedy or actions for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
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, Quantity: 1,721 systems 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.