FDA-Device2023-12-13Class II
DRX Revolution Mobile X-Ray System
Carestream Health, Inc.
Hazard
Unexpected failure of electrical components within the CPI generator.
Sold states
Worldwide Distribution: US (Nationwide Distribution); and OUS (Foreign): Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Dominican Rep., Finland, France, Germany, Ghana, Great Britain, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Monaco, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, & Vietnam.
Affected count
3,961 units
Manufactured in
1049 W Ridge Rd, Rochester, NY, United States
Products
DRX Revolution Mobile X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0437-2024Don't want to check this manually?
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