Philips S7-3t Ultrasound Transducer Probes Recalled for Labeling Clarification

Plain-English summary

Philips Ultrasound, Inc. has recalled 171,322 S7-3t Transducer Probes distributed nationwide in the United States. The recall has been issued to provide clarification and labeling to define the useful life of the ultrasound transducers in field use.

The affected probes are identified by specific model numbers and unique device identifiers (UDIs). Users should verify whether they have affected units by checking the model numbers and UDIs provided in the FDA notice and review any updated labeling or guidance from the manufacturer.

This is a Class III recall, indicating that use of the product is unlikely to cause serious adverse health consequences. Facilities should maintain contact with Philips for any additional information or updated labeling guidance regarding the useful life of these transducers.

The recalled product

Product

S7-3t Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• labeling-defect

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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