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.
Enforcement
- Recall Number
- Z-0774-2014
- Event ID
- 67060
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Carestream Health Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 5, 2014
- Initiation Date
- August 20, 2013
- Classification Date
- January 29, 2014
- Termination Date
- June 28, 2016
- Address
- 150 Verona St, Rochester, NY, 14608-1733, United States
Description
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.
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.
Serial Numbers 5049, 5073, 5133, 5162
Nationwide Distribution including TX, IL, and GA.
4 units