Philips S8-3t Transducer Probe Labeling Clarification for Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling the S8-3t Transducer Probe. This recall affects approximately 171,322 units distributed nationwide in the United States.

The FDA has classified this as a Class III medical device recall. The recall is being issued to provide clarification and labeling needed to properly define the useful life of the ultrasound transducers in clinical settings.

Healthcare facilities and medical professionals using affected S8-3t Transducer Probes should review the updated labeling and guidance from Philips Ultrasound, Inc. regarding the product's useful life and appropriate use parameters.

For additional information or questions about this recall, healthcare providers should contact Philips Ultrasound, Inc.

The recalled product

Product

S8-3t Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• mis-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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