Philips L12-3 Ultrasound Transducer Probe Recalled to Clarify Useful Life Labeling

Plain-English summary

Philips Ultrasound, Inc. is recalling 171,322 L12-3 Transducer Probes distributed nationwide in the United States. This FDA Class III recall addresses the need for clarification and labeling to define the useful life of ultrasound transducers in clinical field use.

The recalled devices are identified by multiple model numbers including 989605412072, 989605492481, 989605438571, and others, along with associated production batches and UDI codes. The recall is intended to provide improved documentation and labeling clarity regarding the transducers' useful life, durability, and operational parameters.

Healthcare facilities and ultrasound providers should consult the FDA recall notice for complete information on specific model numbers, production batches, and updated labeling guidance from Philips Ultrasound, Inc.

The recalled product

Product

L12-3 Transducer Probe

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device

Hazard

• labeling-deficiency

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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