Carestream DRX Evolution System recall
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation…
Why was Carestream DRX Evolution System recalled?
Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.
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?
Serial Numbers 5049, 5073, 5133, 5162
- Product
- Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation…
- Recalling firm
- Carestream Health Inc.
- Quantity
- 4 units
- Distribution
- Nationwide Distribution including TX, IL, and GA.
- Recall date
- February 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)