Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life

Plain-English summary

Philips Ultrasound, Inc. is recalling Philips S5-1 Transducers (Model No. 989605412082, 989605440682, 989605440681, 989803002101) because the devices were refurbished beyond their useful life.

Approximately 5,230 units have been 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, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.

Devices refurbished beyond their useful life may not perform as intended and could compromise patient safety. Healthcare providers and patients who have received or are using affected transducers should contact Philips Ultrasound for guidance on device inspection and potential replacement options.

The recalled product

Product

Philips S5-1 Transducer.

Manufacturer

Philips Ultrasound, Inc

Category

Medical Device — Ultrasound Transducer

Hazard

• device-malfunction
• refurbishment-beyond-useful-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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