FDA DevicesClass II
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X...
Published: January 7, 2026Recall ID: Z-1007-2026Category: devicesCountry: US
Reason for Recall / Hazard
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Product Description & Identification
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Affected Products
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Additional Source Details
| Field | Value |
|---|---|
| City | Bothell |
| State | WA |
| Event id | 98102 |
| Address 1 | 22100 Bothell Everett Hwy |
| Address 2 | N/A |
| 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 |
| Postal code | 98021-8431 |
| Report date | 20260107 |
| Product type | Devices |
| Product quantity | 1,721 systems |
| Reason for recall | Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20220714 |
| Initial firm notification | Letter |
| Center classification date | 20251231 |
Overview
- Recalling FirmPhilips Ultrasound, LLC
- StatusCompleted
- Risk LevelClass II
- DistributionWorldwide - 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.