CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report
Carestream DRX Evolution System recalled by Carestream Health
Carestream Health is recalling Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a, distributed nationwide in the US. The recall was initiated on 20 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0774-2014
- FDA event ID
- 67060
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2013
- FDA classified
- 29 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 20 Aug 2013 | Recall initiated by company | |
| 29 Jan 2014 | Classified by FDA | +162 days |
| 5 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including TX, IL, and GA.
Questions about this recall
Is Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a recalled?
Yes. Carestream Health recalled Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a on 20 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0774-2014.
Why was it 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.
Which lots are affected?
Serial Numbers 5049, 5073, 5133, 5162
Where was it sold?
Nationwide Distribution including TX, IL, and GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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