FDA Recalls Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling the S5-1 Transducer, an ultrasound device used in medical imaging. The recall involves approximately 5,230 units.

These transducers were refurbished beyond their useful life. The refurbishment of devices beyond their intended operational lifespan is the reason for this recall.

The affected devices were distributed domestically throughout the United States and internationally to numerous countries worldwide, including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Japan, Mexico, the Netherlands, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, the United Kingdom, and Vietnam.

For additional information about this recall and the specific affected devices, users should contact Philips Ultrasound, Inc.

The recalled product

Product

Philips S5-1 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• age-degradation
• device-reliability

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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