Medical device recalls Moderate risk

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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