Carestream Health, Inc. recalls DRX Revolution Mobile X-Ray System
- Recall date
- October 2, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0437-2024
- FDA classification
- Class II
- Brand / firm
- Carestream Health, Inc.
- Sold / distributed
- 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, Ir…
Why it was recalled
Unexpected failure of electrical components within the CPI generator.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DRX Revolution Mobile X-Ray System
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