FDA-Device2025-07-09Class II
Philips S5-1 Transducer.
Philips Ultrasound, Inc
Hazard
Ultrasound transducer devices were refurbished beyond their useful life.
Sold states
Domestic: Nationwide Distribution; Foreign: 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 Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.
Affected count
5,230 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips S5-1 Transducer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2025Don't want to check this manually?
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