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Carestream Health, Inc. recalls DRX Revolution Mobile X-Ray System
Recalled December 13, 2023 · FDA recall Z-0437-2024 · Carestream Health
Hazard
Unexpected failure of electrical components within the CPI generator. · FDA Class II
Units
3,961 units
Sold at
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.
Description
Unexpected failure of electrical components within the CPI generator.
Product
DRX Revolution Mobile X-Ray System
Manufacturer(s)
Carestream Health, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →