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Digi-Lite IP Linear Probe

RIMED LTD. · Model Digi-Lite IP Linear Probe · UDI-DI 07290016734034

ITX Prescription
1
510(k) clearances
4,015
Adverse events (23 deaths)
147
Recalls
396
Facilities

Description

The Digi-Lite IP Linear Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the Digi-Lite to enable it to perform a medical purpose

Recalls

DateFirmReason
2025-11-17Sheathing Technologies IncVaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05Philips Ultrasound, IncTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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Data 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.