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Philips Ultrasound, Inc: Philips OMNI II TEE Ultrasound Transducer

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Ultrasound, Inc
Product
Philips OMNI II TEE Ultrasound Transducer
Reason / hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-09-05
Code info
Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Reedsville
State
PA
Country
United States
Event id
97643
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