Philips L8-4 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling 5,230 Philips L8-4 ultrasound transducers (Model No. 989605440811 and 989605440812). The recalled devices were refurbished beyond their useful life, which may affect device reliability and performance.

Ultrasound transducers that are refurbished beyond their intended service life may not maintain proper performance specifications and could pose a risk in clinical diagnostic settings.

The affected transducers were distributed nationwide throughout the United States and internationally to countries including Australia, Canada, China, France, Germany, Japan, and the United Kingdom. These devices were supplied to medical imaging centers, hospitals, and healthcare facilities.

Healthcare providers and clinicians currently using the affected L8-4 transducers should discontinue use and contact Philips Ultrasound, Inc. for information on replacement or repair options.

The recalled product

Product

Philips L8-4 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound diagnostic imaging

Hazard

• device-degradation
• malfunction

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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