OMNI III TEE Ultrasound Transducer Probe labeling and useful life clarification

Plain-English summary

The OMNI III TEE Transducer Probe, manufactured by Philips Ultrasound, Inc., is the subject of this labeling clarification recall. The FDA has determined that improved labeling is needed to clearly define the useful life of these ultrasound transducers in clinical settings.

Philips is providing clarified labeling to ensure healthcare professionals have accurate information about the device's useful life and appropriate maintenance requirements.

Approximately 171,322 units of the OMNI III TEE Transducer Probe (Model No. 989605440702) have been distributed nationwide across the United States.

Healthcare facilities and clinicians currently using this device should review and implement the updated labeling information provided by Philips Ultrasound, Inc.

The recalled product

Product

OMNI III TEE Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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