Philips L12-4 Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling 5,230 L12-4 ultrasound transducers (model numbers 989605427122, 989605451171, 989605434813, 989605434812, 989605477121, and 989605434811) that were refurbished beyond their useful life. The devices have components that have exceeded their designed operational lifespan.

Medical devices that have been refurbished beyond their intended service life may not perform reliably. Transducers in this condition may experience degraded function or failure during use.

The recalled devices were distributed nationwide in the United States and to more than 40 countries worldwide, including Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom.

Facilities using these devices should stop using them immediately and contact Philips Ultrasound, Inc. for replacement, repair, or disposal guidance. Reference FDA Recall Number Z-2055-2025 for more information about affected lot numbers and serial codes.

The recalled product

Product

Philips L12-4 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Equipment

Hazard

• device-failure
• performance-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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