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LELTEK
LELTEK INC. · Model LU710LH · UDI-DI 04719882150104
10
510(k) clearances
2,748
Adverse events (35 deaths)
300
Recalls
220
Facilities
Description
The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Philips Ultrasound, LLC | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of |
| 2026-08-07 | Philips Ultrasound, LLC | Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measure |
| 2025-10-31 | Philips Ultrasound, LLC | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-10-09 | B-K Medical A/S | GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-lif |
| 2025-09-18 | GE Medical Systems, LLC | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.