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

Plain-English summary

Philips Ultrasound, Inc. is recalling the Philips L8-4 Transducer (Model Nos. 989605440811, 989605440812). According to the FDA, the devices were refurbished beyond their useful life.

Approximately 5,230 units were affected by this recall. The devices were distributed domestically nationwide and internationally to countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and others.

Users of affected transducers should contact Philips Ultrasound, Inc. for instructions on return or replacement. Additional information is available from the FDA's Medical Device Recalls database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2056-2025.

The recalled product

Product

Philips L8-4 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-degradation

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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