Philips S4-1 Ultrasound Transducer Probes Recalled for Useful Life Clarification

Plain-English summary

Philips Ultrasound, Inc. is recalling the S4-1 Transducer Probe, an ultrasound transducer device. Approximately 171,322 units have been distributed nationwide in the United States. The recalled devices are Model Numbers 989605389271, 989605389272, and 989605364993, along with specific batch and serial identifiers as documented by the FDA.

The recall was initiated to provide clarification and labeling that defines the useful life of these ultrasound transducers in clinical use. The FDA classified this action as a Class III recall.

Healthcare providers using the S4-1 Transducer Probe should review the updated labeling regarding the device's useful life. Contact Philips Ultrasound or the FDA for additional guidance related to the clarified labeling.

The recalled product

Product

S4-1 Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• product-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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