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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 20, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 28, 2004
Recall NumberZ-0728-04
Recall Event ID 28438
510(K)NumberK001341 
Product Classification System, X-Ray, Stationary - Product Code KPR
ProductKodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system 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 Serial Numbers affected: 4193-5702, 4193-5704, 4193-5705, 4193-5706, 4193-5708
FEI Number 1315356
Recalling Firm/
Manufacturer		 Eastman Kodak Co
343 State St
Rochester NY 14650-1131
For Additional Information ContactJames Burns
585-726-6383
Manufacturer Reason
for Recall		Defective component in overhead tube support balancer may cause the suspended load to fall.
FDA Determined
Cause 2		Other
Action2/20/2004: Field representatives notified the customer in China that the unit should not be used until the OTS Balancer component can be repaired/replaced.
Quantity in Commerce3 units
DistributionAmsterdam, China and Kuwait.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPR
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