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U.S. Department of Health and Human Services

Class 2 Device Recall Kodak DirectView DR 71 System

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  Class 2 Device Recall Kodak DirectView DR 71 System see related information
Date Initiated by Firm October 20, 2005
Date Posted December 08, 2005
Recall Status1 Terminated 3 on December 30, 2005
Recall Number Z-0274-06
Recall Event ID 33931
510(K)Number K001341  
Product Classification System, X-Ray, Stationary - Product Code KPR
Product KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; ceiling-mounted x-ray tube; x-ray generator timing and distribution unit.
Code Information s/n DR71000121 and DR71000123.
Recalling Firm/
Manufacturer		 Eastman Kodak Co
343 State St
Rochester NY 14650
For Additional Information Contact James Burns
585-726-6383
Manufacturer Reason
for Recall		 Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
FDA Determined
Cause 2		 Other
Action Letters dated 10/20/2005 were hand carried by Kodak Field Service Reps. Kodak Field Engineers inspected units and found the two defective units (both in China).
Quantity in Commerce 3
Distribution DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
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 = ANALOGIC CORP.
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