Philips L12-4 Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling Philips L12-4 Transducer devices (Model Nos. 989605427122, 989605451171, 989605434813, 989605434812, 989605477121, 989605434811) because the ultrasound transducers were refurbished beyond their useful life. A total of 5,230 units have been affected by this recall.

The recalled units were distributed nationwide in the United States and internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Türkiye, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

Consumers and healthcare facilities in possession of affected Philips L12-4 transducers should stop using the devices and contact Philips Ultrasound, Inc. for further guidance regarding the recall and appropriate next steps for handling the affected units.

The recalled product

Product

Philips L12-4 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-degradation
• refurbished-beyond-life

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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