Philips S3-1 Transducer Probe Recall: Useful Life Labeling Clarification

Plain-English summary

Philips Ultrasound, Inc. is recalling 171,322 S3-1 Transducer Probes, ultrasound diagnostic devices distributed nationwide in the United States. The recall is classified as Class III by the FDA.

The recall has been initiated to provide clarification and labeling to define the useful life of these ultrasound transducers in the field. This involves updating the product labeling to properly specify the useful life.

Healthcare facilities and medical professionals who use S3-1 Transducer Probes are affected by this recall. The recall applies to multiple model numbers and serial numbers, as specified by the FDA.

For updated labeling and product information, contact Philips Ultrasound, Inc. Refer to FDA recall number Z-2390-2025 for details on affected units and model numbers.

The recalled product

Product

S3-1 Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Diagnostic

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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