Philips EPIQ Elite Ultrasound System Recalled for Software Error
Philips is recalling 219 EPIQ Elite Diagnostic Ultrasound Systems due to a software issue that may cause inaccurate blood flow velocity measurements and potential misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of misdiagnosis due to inaccurate measurements, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Ultrasound, LLC is recalling 219 units of the Philips EPIQ Elite Diagnostic Ultrasound System, Model # 795234. The recall affects systems running software version 14.0 and includes specific UDI codes. The devices were distributed worldwide, including in the United States and various countries in Europe, Asia, and the Philippines.
The recall is due to a software issue where the Doppler sample is displayed shallower than its actual measurement location. This error can potentially lead to inaccurate blood flow velocity measurements and misdiagnosis.
Healthcare providers and consumers should contact Philips Ultrasound, LLC for instructions on how to address the software issue. The source text does not specify a particular action for end-users beyond the general recall notice.
The recalled product
- Product
- Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
- Manufacturer
- Philips Ultrasound, LLC
- Affected units
- 219
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 (1)
- All Philips EPIQ Elite Ultrasound Systems running software version 14.0
Distribution
Related recalls
Same manufacturer · Philips Ultrasound, LLC
See all →- ModerateUltrasound systems recalled over unexpected reboots that damage the transducer
FDA (Devices) · 2026-01-07
- ModerateParasite tests, SKU 2A178, recalled for lacking premarket approval or clearance
FDA (Devices) · 2025-12-10
Same hazard · misdiagnosis
See all →- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23