Carestream DRX Evolution System — Class II medical device recall Z-0774-2014

Terminated recall by Carestream Health Inc., reported 2014-02-05, distributed nationwide. Carestream received a report of an exposure being initiated without a patient image captured. The patient was

Recall number	`Z-0774-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Carestream Health Inc., Rochester, NY, United States
Recall initiated	2013-08-20
Classified	2014-01-29
Reported by FDA	2014-02-05
Terminated	2016-06-28
Distributed	Nationwide (US)
Quantity	4 units
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 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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0774-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.