Carestream DRX Evolution System recall
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays…
Why was Carestream DRX Evolution System recalled?
Due to potential for an x-ray exposure technique change.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software
- 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…
- Recalling firm
- Carestream Health Inc.
- Quantity
- US: 49 units; Foreign: 183 units (revised)
- Distribution
- Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
- Recall date
- August 21, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)