ClearanceBrief
510(k) K014191 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540

ApplicantPhilips Medical Systems, Andover MA, US
DecisionSubstantially Equivalent, Jan 7, 2002
ReceivedDec 21, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K014191

DateFirm and productCodeLinked 510(k)
Mar 24, 2026Philips Ultrasound, Inc
Philips OMNI II TEE Ultrasound Transducer
Open, Classified		 ITXNone listed
Aug 22, 2025Philips Ultrasound, Inc
7.5MHZ Endo Transducer Probe
Open, Classified		 ITXNone listed
Aug 22, 2025Philips Ultrasound, Inc
OMNI II TEE Transducer Probe
Open, Classified		 IYNNone listed
Aug 22, 2025Philips Ultrasound, Inc
OMNI III TEE Transducer Probe
Open, Classified		 IYNNone listed
Jun 22, 2005Philips Ultrasound, Inc.
Envisor, M2540 Diagnostic Ultrasound System
Terminated		 IYNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.