Philips X8-2t Transducer Probe Labeling Clarification for Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling the X8-2t Transducer Probe, a medical device used in ultrasound equipment. The recall affects 171,322 units distributed nationwide. The affected devices are identified by Model Numbers 989605455171, 989605400802, 989605409562, and 989605414122, along with specific UDI (Unique Device Identifier) codes.

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

Healthcare facilities and medical professionals who use this transducer probe should contact Philips Ultrasound, Inc. for updated labeling information regarding the devices' useful life definition. For additional details on specific serial numbers and affected lot codes, healthcare providers should refer to FDA recall notice Z-2413-2025.

The recalled product

Product

X8-2t Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• labeling-issue

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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