Carestream DRX Evolution X-Ray System Recalled for Exposure Technique Change
Carestream Health is recalling DRX Evolution X-Ray systems due to a potential change in x-ray exposure technique.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential change in x-ray exposure technique, which poses a risk of harm (excessive radiation) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Carestream Health Inc. is recalling the DRX Evolution System, a permanently installed diagnostic x-ray system used for examining various anatomical regions. The recall is due to a potential for an x-ray exposure technique change.
The recall affects 49 units in the United States and 183 units in foreign countries. The affected systems are those using V5.5.410.33 MR2 Software. Distribution was worldwide, including the United States (nationwide) and countries such as Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The FDA has classified this recall as Class II. Consumers and healthcare facilities should contact Carestream Health Inc. for further instructions regarding the affected equipment.
The recalled product
- Product
- Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
- Manufacturer
- Carestream Health Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software
Distribution
Distributed nationwide across the United States.
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