# FDA recall Z-0437-2024

> **Carestream Health, Inc.** · Class II · device recall initiated 2023-10-02.

## Product

DRX Revolution Mobile X-Ray System

## Reason for recall

Unexpected failure of electrical components within the CPI generator.

## Distribution

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.

## Key facts

- **Recall number:** Z-0437-2024
- **Recalling firm:** Carestream Health, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-02
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0437-2024

## Citation

> AI Analytics. FDA recall Z-0437-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0437-2024. Source: US FDA. Licensed CC0.

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