Medical Device Recall: Philips X6-1 Transducer.
Philips Ultrasound, Inc · May 28, 2025
Reason for Recall
Ultrasound transducer devices were refurbished beyond their useful life.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
5,230 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2065-2025
Status: ongoing
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