Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system 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 wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
- Company
- Carestream Health, Inc.
- Recall Initiated
- July 9, 2014
- Posted
- August 10, 2014
- Terminated
- May 12, 2017
- Recall Number
- Z-2177-2014
- Quantity
- 589 systems
- Firm Location
- Rochester, NY
Reason for Recall
An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.
Distribution
Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
Lot / Code Info
The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
Root Cause
Device Design
Action Taken
Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks