Ultrasound systems recalled over unexpected reboots that damage the transducer
Philips Ultrasound is recalling 1,721 EPIQ Ultrasound Systems used with the X5-1c transducer because the system may experience an unexpected automatic reboot, resulting in damage to the transducer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is damage to the transducer, with no patient harm or reported injury.
Plain-English summary
Philips EPIQ Ultrasound Systems, in the models listed in the enforcement record including REF 795200, 795201, 795231, 795232 and 795234, used in conjunction with the X5-1c transducer, are being recalled.
The record, marked retroactive, states that the ultrasound may experience an unexpected automatic reboot, resulting in damage to the transducer.
The record lists 1,721 systems running software versions 9.0, 9.01 and 9.02, with REF and UDI pairings listed in the enforcement record. Distribution was worldwide, including nationwide across the United States. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is damage to the transducer, and no injuries are reported. Facilities should follow Philips' instructions.
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
- Manufacturer
- Philips Ultrasound, LLC
- Affected units
- 1,721
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Software Version Numbers: 9.0
- 9.01
Distribution
Related recalls
Same manufacturer · Philips Ultrasound, LLC
See all →- SeverePhilips Lumify Diagnostic Ultrasound System Recalled for Connection Issues
FDA (Devices) · 2026-10-28
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- ModerateParasite tests, SKU 2A178, recalled for lacking premarket approval or clearance
FDA (Devices) · 2025-12-10
Similar recalls
- HighPhilips EPIQ Ultrasound Systems Recalled for Software Lock-up Defect
FDA (Devices) · 2021-09-29
- ModeratePhilips X5-1 ultrasound transducers were refurbished beyond their useful life
FDA (Devices) · 2025-07-09
- ModeratePhilips C5-1 ultrasound transducers were refurbished beyond their useful life
FDA (Devices) · 2025-07-09
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
- HighPhilips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings
FDA (Devices) · 2014-03-26
- HighPhilips C9-5EC Ultrasound Transducer Devices Recalled
FDA (Devices) · 2025-07-09