FDAFDA · Food and drugs·Recall number Z-0774-2014
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
Published February 5, 2014 · Recall initiated: August 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carestream Health Inc.
- Distributor
- Nationwide Distribution including TX, IL, and GA.
- Lot
- Serial Numbers 5049, 5073, 5133, 5162
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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