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U.S. Department of Health and Human Services

Class 2 Device Recall Kodak DirectView DR 7500 Diagnostic XRay System

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  Class 2 Device Recall Kodak DirectView DR 7500 Diagnostic XRay System see related information
Date Initiated by Firm July 09, 2014
Date Posted August 10, 2014
Recall Status1 Terminated 3 on May 12, 2017
Recall Number Z-2177-2014
Recall Event ID 68727
510(K)Number K051258  
Product Classification System, x-ray, stationary - Product Code KPR
Product 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.
Code Information The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
Recalling Firm/
Manufacturer		 Carestream Health, Inc.
1049 W Ridge Rd
Rochester NY 14615-2731
For Additional Information Contact
585-781-1997
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 589 systems
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = EASTMAN KODAK COMPANY
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