DRX Revolution Mobile X-Ray System
Reported: December 13, 2023 Initiated: October 2, 2023 #Z-0437-2024
Product Description
DRX Revolution Mobile X-Ray System
Reason for Recall
Unexpected failure of electrical components within the CPI generator.
Details
- Recalling Firm
- Carestream Health, Inc.
- Units Affected
- 3,961 units
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
DRX Revolution Mobile X-Ray System. Recalled by Carestream Health, Inc.. Units affected: 3,961 units.
Why was this product recalled? ▼
Unexpected failure of electrical components within the CPI generator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0437-2024.
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